Hospital Sepsis Program Core Elements Score

 This measure includes 29 attestations, several of which are duplicative. For facilities that have already completed PSSMs and maintain a well-functioning sepsis program, this measure would represent a relatively light lift. However, for hospitals that have not yet completed these foundational elements, implementation would constitute a significant operational and resource burden. Should this measure be adopted, the Kansas Hospital Association suggests that the questions be reviewed to reduce both the number and duplication. 

Executive Summary

I support CMS’s overarching goal to reduce sepsis morbidity and mortality. However, I have serious concerns about implementing a structural, attestation‑based requirement tied to core reimbursement for all acute care hospitals. As written, the Hospital Sepsis Program Core Elements Score risks punishing smaller, rural, and non‑corporatized institutions that lack resources to meet prescriptive program inputs—especially dedicated coordinator FTEs at every site—without a clear, validated link to measurable patient outcome improvement in these settings. A phased, flexible, and validated approach—preferably as pay‑for‑reporting or bonus/incentive funding with hardship protections—would better advance CMS’s aims while maintaining equity.

Background and Context

• CMS is considering a structural measure, Hospital Sepsis Program Core Elements Score (MUC2025‑047), that assesses hospitals’ leadership support, personnel resources, and adoption of program practices aligned to CDC’s Hospital Sepsis Program Core Elements. [p4qm.org]
• CDC’s Core Elements are a useful manager’s framework (leadership, accountability, multi‑professional expertise, action, tracking, reporting, education) intended to optimize sepsis programs across diverse hospital settings. [cdc.gov]
• Recent communications to sepsis stakeholders note that CMS’s proposal accompanies outcome measures (community‑onset sepsis mortality; 30‑day readmissions). While many professional groups are supportive, the policy details matter for equitable implementation. [sepsis.org], [endsepsis.org]

Key Concerns

1. Resource Inequity & Staffing Model Misfit

   • Many small/rural hospitals cannot support a dedicated on‑site sepsis coordinator per location. In large systems, a single coordinator often covers multiple sites; in independent hospitals, coverage is shared across quality portfolios. Mandating site‑specific FTEs or rigid accountability structures could divert scarce resources without proven benefit.
   • Even within integrated systems, our own comparative notes indicate that bundle compliance (SEP‑1) has not consistently correlated with improved outcomes nor physician buy‑in, underscoring that structure/process alone are insufficient without context, culture, and data feedback loops.

    

2. Attestation Vulnerability & Administrative Burden
   • A non‑weighted, attestation‑based score invites box‑checking, variable interpretation, and potential data integrity risks (falsification or optimistic self‑reporting). If tied to core reimbursement, the incentive to attest success—even without genuine practice change—rises. [p4qm.org]
   • CDC’s own description emphasizes the Core Elements as guidance, not prescriptive rules; converting them into a binary structural requirement risks compliance theater rather than authentic improvement. [cdc.gov]
   •  
3. Unclear Causal Pathway to Outcomes in Under‑resourced Settings
   • CDC highlights associations between hospital sepsis programs and reduced mortality/LOS/costs; but general associations do not guarantee uniform effect across low‑volume, low‑resource environments—especially if staff are stretched and multi‑role. A national mandate should be preceded by validation that structural scores predict outcome gains across heterogeneous rural/community hospitals. [cdc.gov]
   •  
4. Risk of Unintended Consequences
   • Tying this structural measure to core reimbursement could widen disparities, forcing small hospitals to cut other patient‑safety work to fund program “inputs” (e.g., coordinator time) that may not yield commensurate outcome benefits locally.
   • Hospitals under financial strain may consolidate services or reduce access—the opposite of CMS’s equity and access goals.

Recommendations to CMS

A. Phase Implementation & Use Pay‑for‑Reporting First
Adopt the Core Elements Score initially as pay‑for‑reporting with transparent feedback (like NHSN facility reports), not as a condition for full payment update. Pair with technical assistance and learning collaboratives focused on rural/independent hospitals. [cdc.gov]

B. Allow System‑Level Accountability & Flexible Staffing Models
Permit regional/system‑level sepsis leadership and shared coordinator coverage where on‑site FTEs are infeasible. Evaluate accountability through demonstrated activities (e.g., multidisciplinary committees, education plans, chart reviews) rather than fixed FTE counts. [cdc.gov]

C. Strengthen Verification Beyond Attestation
Replace simple attestation with lightweight verification:

• Periodic documented evidence (meeting notes, education rosters, workflows).
• Targeted audits or data triangulation using NHSN survey responses and EHR artifacts.
• Graduated confidence scoring to reduce falsification risk. [cdc.gov]

D. Tie Dollars to Improvement and Outcomes, Not Just Structure
If CMS seeks financial levers, prioritize bonus/incentive payments for risk‑adjusted improvement in outcome measures (e.g., mortality/readmissions) and for closing equity gaps, rather than penalizing hospitals that lack resources to fully meet structural inputs. [sepsis.org], [endsepsis.org]

E. Build a Rural/Small‑Hospital Hardship Pathway
Create explicit hardship exemptions or alternative pathways for rural PPS Critical Access Hospitals and independent facilities, with scaled expectations and focused support.

F. Pilot & Evaluate Before Nationwide Mandate
Conduct pilots in diverse markets (including rural) to confirm that the Core Elements Score predicts outcome gains and to quantify costs/benefits and staffing feasibility prior to tying performance to core reimbursement. [cdc.gov]

Conclusion

CDC’s Core Elements are a thoughtful framework. CMS can leverage them without inadvertently harming small and rural hospitals. A phased, flexible, validated approach—focusing on support, verification, and measured outcome improvement—will better align with CMS’s goals of improving sepsis care equitably across all communities.

Rationale: This measure will assess uptake of evidence-based sepsis program best practices described in the CDC Hospital Sepsis Program Core Elements and will provide guidance to acute care hospitals for monitoring and optimizing hospital management and outcomes of sepsis, leading to improved patient outcomes. Sepsis is a major contributor to hospital mortality and long-term disability, with over 1.7 million hospitalizations annually in the U.S. and 350,000 resulting in death or hospice discharge. Effective hospital sepsis programs require strong leadership, multidisciplinary collaboration, and dedicated resources, including sepsis coordinators and structured protocols for early recognition and treatment. Programs benefit from standardized screening tools, care pathways, rapid response teams, and “Code Sepsis” protocols, all aimed at improving timely intervention and reducing mortality. Education for health care staff, patients, and caregivers is essential, especially given the high risk of post-sepsis complications and rehospitalization. Feedback from patients on the technical expert panel (TEP) for this measure indicated the strong importance of this measure target to patients.  This measure will track which hospitals attest to having these best practices in place.

ECRI, a global nonprofit advancing evidence-based healthcare, has submitted the attached comments on the MUC with an emphasis on measures most relevant to patient safety and diagnostic excellence. 

ECRI supports the CMS Measures Under Consideration (MUC) List and its role in advancing meaningful, high-value measurement. Of particular significance are the measures focused on chronic disease management and diagnostic safety. Strengthening measurements in these domains supports more efficient, timely, and coordinated care across the healthcare system to better serve patients. 

The attached comments from ECRI include recommendations on the importance of patient-reported outcomes, minimizing unnecessary reporting burdens, and feedback in support of the following measures: 

• Timely Follow-up on Abnormal Screening Mammograms for Breast Cancer Detection (MUC2025-042)
• Timely Follow-up on Positive Stool-based Tests for Colorectal Cancer Detection (MUC2025-043)
• Adult Community-Onset (CO) Sepsis Standardized Mortality Ratio (MUC2025-045)
• Hospital Sepsis Program Core Elements Score (MUC2025-047)
• Hospital 30-Day, All-Cause, Risk-Standardized Readmission Rate Following Sepsis Hospitalization (MUC2025-055)
• Hospital Harm - Postoperative Venous Thromboembolism (MUC2025-067)

SHEA supports the adoption of the Hospital Sepsis Program Core Elements Score as a structural measure that advances the recognition of sepsis as a hospital-wide patient safety priority. This measure aligns closely with the CDC’s evidence-based framework and reflects best practices observed in high-performing health systems. While SHEA shares CMS’s overarching goal of improving sepsis care and outcomes, the primary value of this measure lies in its potential to foster durable organizational capability and accountability for sepsis management.

The American College of Emergency Physicians (ACEP) supports CMS’ efforts to advance national sepsis quality measurement. We support the systems approach but continue to have reservations on some of the time sensitive elements given as examples. There is increasing evidence that rapid identification and treatment of patients with septic shock is important but applying those metrics to patients without shock can be detrimental and is not evidence based. For example, treatment with broad spectrum antibiotics before the source of the infection is known, may be detrimental not only to the patient but may contribute to resistance to antibiotics for other patients. We support this measure but ask that CMS review and refine some of the long-held metrics which are now scientifically questioned. 

Going forward we suggest CMS reconsider its ‘one-size’ fits all definition and treatment of sepsis. Sepsis is a very complicated, multifactorial condition. While septic shock has a somewhat common pathway for treatment and stabilization, lesser forms of sepsis do not share either the common pathway or the urgency of treatment. While we have seen gains in the outcome of patients with sepsis, the literature would suggest that there may be harm done to patients who initially present and are treated as meeting sepsis criteria but eventually have another cause for their symptoms. 

Establishing expectations for hospital-wide infrastructure, leadership engagement, multidisciplinary collaboration, and continuous quality improvement is foundational to improving sepsis outcomes and aligns closely with the CDC’s evidence-based framework as well as best practices observed in high-performing health systems. We would add that such infrastructure should actively engage those clinicians on the front lines, who make this diagnosis and treat this and similar conditions daily. 

As a multi hospital system, Bon Secours Mercy Health is concerned regarding the number of structural measures linked to “programs” requiring discrete time and people resources.  For smaller hospitals – it would be beneficial to acknowledge that this work may be a significant burden due to smaller available medical staff and require using shared resources and consolidating expertise into single committees.     

On behalf of the Michigan Hospital Medicine Safety Consortium (HMS) Coordinating Center, we strongly support the adoption of the Hospital-Level, Risk-Standardized 30-day All-Cause Readmission measure for sepsis. HMS is a statewide collaborative of 68 diverse Michigan hospitals that has demonstrated measurable improvements in sepsis care since launching our sepsis initiative in 2021. Our work extends across the full continuum of sepsis care, from initial presentation through post-hospital follow-up, informed by a detailed sepsis registry that includes patient-reported outcomes collected 30-90 days post-discharge. 

Sepsis readmissions represent a significant quality gap, with 30-day readmission rates ranging from 17% to 26%. We believe outcome measures like the Sepsis Readmission measure provide essential insights into the effectiveness of care across the entire continuum and work in concordance with process measures like SEP-1 that ensure timely, evidence-based care during the index hospitalization. The combination of accountability for acute care delivery through SEP-1, structural support through the Hospital Sepsis Program Core Elements, and outcome tracking through readmission measures creates a comprehensive measurement framework. Maintaining all three elements of measurement—structure, process, and outcomes—provides the most effective approach to protecting patients and improving sepsis care nationwide.

On behalf of the Michigan Hospital Medicine Safety Consortium (HMS) Coordinating Center, we strongly support the adoption of the Hospital Sepsis Program Core Elements Score. HMS is a statewide collaborative of 68 diverse Michigan hospitals that has demonstrated measurable improvements in sepsis care since launching our sepsis initiative in 2021. As a partner in developing the Hospital Sepsis Program Core Elements, we have direct experience with how structural measures guide effective hospital sepsis programs. Through our detailed sepsis registry and quality improvement work across Michigan, we have seen significant improvements in antibiotic delivery times, care practices, and mortality trends. This experience has reinforced a critical lesson: structural improvements create the foundation for better care, but process-level accountability drives the timely, bedside interventions that ultimately save lives.

Sepsis is a medical emergency that requires timely recognition and treatment, and quality measurement must reflect all three pillars: structure, process, and outcomes. We support the Hospital Sepsis Program Core Elements to assess sepsis care structure and outcome measures such as risk-adjusted mortality and 30-day all-cause readmissions. We believe new structural and outcome measures like MUC2025-047 should be adopted alongside existing process measures like SEP-1, rather than as replacements. Maintaining all three elements of measurement—structure, process, and outcomes—provides the most comprehensive approach to protecting patients and improving sepsis care nationwide.

SHM supports adoption of the Hospital Sepsis Program Core Elements Score. Establishing expectations for hospital-wide infrastructure, leadership engagement, multidisciplinary collaboration, and continuous quality improvement is foundational to improving sepsis outcomes and aligns closely with the CDC’s evidence-based framework as well as best practices observed in high-performing health systems.

We acknowledge that assessment of programmatic elements using surveys conducted by the National Healthcare Safety Network (NHSN) may involve some degree of subjectivity and variability in interpretation across hospitals. However, we believe these challenges are manageable and should not preclude adoption. Clear guidance, standardized definitions, iterative refinement of survey instruments, and targeted auditing processes can improve consistency over time. Importantly, the value of this measure lies in promoting durable organizational capability and accountability for sepsis care, rather than prescribing rigid clinical protocols. As such, this structural measure represents a critical step forward in elevating sepsis as a hospital-wide patient safety priority.

While the American Medical Association (AMA) supports the ongoing focus of improving the care provided to individuals with sepsis, we do not support endorsing a structural measure that is based on attestation. We believe that the healthcare ecosystem should focus their efforts on the measures, initiatives, and activities that prioritize the collection and reporting of additional relevant safety data and outcomes and promote interventions that are directly linked to driving improvement. 

In addition, we believe that a measure that examines the outcomes for patients with a diagnosis of sepsis such as MUC2025-045, Adult Community-Onset (CO) Sepsis Standardized Mortality Ratio (SMR), is preferable rather than continuing to require reporting on measures such as the sepsis bundle (SEP-1) or this measure, which are extremely burdensome to report and has not yet demonstrated a link to improving patient outcomes. 

Due to these concerns, the AMA does not support inclusion of this measure in the Hospital Inpatient Quality Reporting Program. 

The AHA supports the CDC’s Hospital Sepsis Core Elements Program and appreciates that this measure would not require any new data collection as it is already part of the annual NHSN survey. However, we hope CMS can share its longer-term strategy to address sepsis in its quality measurement programs; structural measures generally provide less robust assessments of hospital quality as they rely on simple statement attestations as opposed to clinical data. We understand that CMS is considering multiple measures related to sepsis, and thus encourage the agency to share during the Hospital Committee meeting how it sees these various measures complementing each other in the IQR and other programs.

Vizient supports the agency’s efforts to identify measures to help improve sepsis care. However, the MUC2025-047: Hospital Sepsis Program Core Elements Score measure under consideration, which includes patients with a sepsis diagnosis, may be unnecessary. For example, several of the contemplated measures introduce new requirements which appear to overlap with existing measures that hospitals report, such as the Severe Sepsis and Septic Shock: Management Bundle (SEP‑1). Vizient is concerned that introducing multiple new sepsis‑related measures, especially if existing measures are retained, risks increasing burden without clear evidence regarding which measurement approach, if any, will be most beneficial in the context of patient care.

We are also concerned that this and other sepsis-related measures currently under consideration suggest that CMS is seeking to add several measures to different quality programs, which runs counter to the agency’s aims to reduce the overall number of measures, decrease burden and streamline program requirements. Given the overlap with SEP-1 and the significant burden associated with SEP‑1, we suggest retiring SEP‑1 and replacing it with significantly fewer measures. 

Vizient also notes that the considered sepsis measures would benefit from undergoing additional review, as these measures have not been used in CMS programs or thoroughly vetted or tested by hospitals. Vizient cautions against advancing measures that have not been rigorously evaluated by experts and tested, as such measures may not achieve their desired outcome, create unintended consequences or prove unworkable in real‑world settings. Vizient believes additional analysis and testing would help to better understand the impacts of these measures, including whether similar benefits can be achieved with fewer measures

The Infectious Diseases Society of America (IDSA), together with our partnering professional societies representing clinicians and researchers involved in sepsis care across healthcare settings, strongly supports CMS’s efforts to advance national sepsis quality measurement. We recognize that no individual measure will be perfect at inception, and that each will require thoughtful implementation, monitoring, and refinement over time. Nonetheless, we believe the propose measure represents an important, necessary step toward improving sepsis care and outcomes.  We support CMS moving forward while continuing to engage stakeholders to address implementation challenges, unintended incentives, and equity implications informed by prior experience with national quality measures. 

IDSA and our partnering societies support adoption of the Hospital Sepsis Program Core Elements Score. Establishing expectations for hospital-wide infrastructure, leadership engagement, multidisciplinary collaboration, and continuous quality improvement is foundational to improving sepsis outcomes and aligns closely with the CDC’s evidence-based framework as well as best practices observed in high-performing health systems.

We acknowledge that assessment of programmatic elements using surveys conducted by the National Healthcare Safety Network (NHSN) may involve some degree of subjectivity and variability in interpretation across hospitals. However, we believe these challenges are manageable and should not preclude adoption. Clear guidance, standardized definitions, iterative refinement of survey instruments, and targeted auditing processes can improve consistency over time. Importantly, the value of this measure lies in promoting durable organizational capability and accountability for sepsis care, rather than prescribing rigid clinical protocols. As such, this structural measure represents a critical step forward in elevating sepsis as a hospital-wide patient safety priority.

On behalf of END Sepsis and the Staunton Foundation I would like to enthusiastically support the inclusion of these three (3) new sepsis measures for use by CMS.  In conjunction with the process measure already in use, SEP-1, these measures focused on hospital sepsis care infrastructure and critical patient outcomes will strengthen accountability by health systems while providing critical quality metrics in the service of care improvement.  Sepsis treatment affects millions of patient lives and families in the US.  Timely, comprehensive care for patients with sepsis can make the difference between life and death, disability or function. Incorporating these measures into CMS quality reporting and value based purchasing programs reflects a major step forward towards a comprehensive national effort to save lives impacted by sepsis.

The extensive attestation requirements create undue administrative burden. We urge CMS to streamline elements to those empirically linked to improved outcomes and allow flexible evidence submission. 

While Premier believes sepsis continues to be an important public health and hospital quality issue, administering a structural measure will not improve outcomes. Premier urges CMS to work with stakeholders to advance the use of AI in its development of new digital quality measures. The use of AI has the potential to increase the availability of real-time, actionable quality data and to reduce provider burden and burnout.

I do not intend to preach to the choir and trust that you understand that this will be your legacy.    Everyone understands the therapeutic benefits of your initiatives.  They save lives and they save billions of dollars in unnecessary medical care.   I ask myself why so long?  But I choose to focus on the end game and that is identifying, treating, and most importantly stopping sepsis in its tracks.  What brings me to you?  Rory Staunton, Rory Staunton, Rory Staunton.   Say his name.  It is his name that his parents have fought since April 1, 2012 to urge action, reform and education.  I commend you and this ground breaking work, and believe me, many are watching.   Make history.   Make this your legacy!

I am writing as a member of the Board of Directors of Sepsis Alliance to offer my appreciation for the work being done to improve outcomes for patients with sepsis and reduce the financial and human cost of sepsis in the United States.  I believe that the proposed measures, if adopted in addition to the existing process measure, SEP-1, will help achieve this goal.  If, however, the proposed measures are adopted as a replacement to the existing accountability measure represented by SEP-1, we will do a disservice to patients with sepsis. 

Sepsis is a medical emergency that requires timely recognition and treatment. During the first Trump Administration, important work was done by CMS to analyze the cost to Medicare of care for patients with sepsis.  That tabulation documented a cost in excess of $40 billion per year in costs for in-patient hospital admission and subsequent skilled nursing facility admission for Medicare patients.  Clearly, this is a significant problem that must be addressed.

I support the CDC Core Elements to assess sepsis care structure and outcome measures such as risk-adjusted mortality and 30-day all-cause readmissions. These measures are important but not sufficient on their own.  Quality measurement must reflect structure, process, and outcomes.

Process measures remain essential to ensure timely and appropriate care for individual patients. SEP-1 is the only nationally standardized process measure for sepsis and provides critical accountability.

New structural and outcome measures should be adopted alongside SEP-1, not in place of it. Maintaining all three elements of measurement is essential to protecting patients, saving lives, reducing costs and improving sepsis care nationwide.

We are the parents of Rory Staunton, a twelve-year-old boy who died from preventable sepsis in April 2012. When Rory became ill, we brought him to a leading New York City hospital. Despite clear signs of sepsis, his condition was not recognized or treated. A small cut sustained while playing basketball led to an infection that progressed to sepsis, with tragic and irreversible consequences.

Our lived experience of loss—one that never truly ends—drives our ongoing work to change how sepsis is recognized, treated, and prevented. In 2012, as a direct result of our advocacy, New York State implemented Rory’s Regulations, requiring hospitals to adopt evidence-based sepsis protocols. These regulations have since saved thousands of lives across the state.

That same year, we founded END SEPSIS: The Legacy of Rory Staunton, a national movement of families, survivors, and advocates working to end preventable deaths and disabilities from sepsis.

We write in strong support of the CDC Core Elements for assessing hospital sepsis care, including both structural requirements and meaningful outcome measures such as risk-adjusted mortality and 30-day all-cause readmissions. A hospital sepsis outcome measure is essential to patient-centered care and aligns with the urgent need to improve transparency and accountability in sepsis treatment across hospitals.

Benchmarking hospital performance in sepsis care is critical to driving improvement and reducing avoidable harm. The CDC Core Elements’ focus on helping hospitals build comprehensive sepsis programs grounded in continuous quality improvement—from early recognition and timely treatment through discharge planning and post-discharge follow-up—has the potential to save lives and prevent long-term disability.

We strongly urge CMS to adopt and implement this sepsis measure, as meaningful outcome accountability and structured hospital sepsis programs are essential to preventing avoidable deaths and ensuring that no family experiences the tragedy that forever changed ours.

The Society of Infectious Diseases Pharmacists (SIDP), together with our partnering professional societies representing clinicians and researchers involved in sepsis care across healthcare settings, strongly supports CMS’s efforts to advance national sepsis quality measurement. We recognize that no individual measure will be perfect at inception, and that each will require thoughtful implementation, monitoring, and refinement over time. Nonetheless, we believe the propose measure represents an important, necessary step toward improving sepsis care and outcomes.  We support CMS moving forward while continuing to engage stakeholders to address implementation challenges, unintended incentives, and equity implications informed by prior experience with national quality measures. 

SIDP and our partnering societies support adoption of the Hospital Sepsis Program Core Elements Score. Establishing expectations for hospital-wide infrastructure, leadership engagement, multidisciplinary collaboration, and continuous quality improvement is foundational to improving sepsis outcomes and aligns closely with the CDC’s evidence-based framework as well as best practices observed in high-performing health systems.

We acknowledge that assessment of programmatic elements using surveys conducted by the National Healthcare Safety Network (NHSN) may involve some degree of subjectivity and variability in interpretation across hospitals. However, we believe these challenges are manageable and should not preclude adoption. Clear guidance, standardized definitions, iterative refinement of survey instruments, and targeted auditing processes can improve consistency over time. Importantly, the value of this measure lies in promoting durable organizational capability and accountability for sepsis care, rather than prescribing rigid clinical protocols. As such, this structural measure represents a critical step forward in elevating sepsis as a hospital-wide patient safety priority.

Support with modification: Supports structured sepsis response programs, however measure is more appropriate for facility quality improvement than Plan-level Star Ratings. 

We have concerns regarding the significant resource intensity required to support affirmative responses for the Sepsis Program Core Elements Measure under current specifications. Demonstrating compliance with multiple programmatic elements, such as governance structures, education, data abstraction, performance monitoring, and improvement activities, requires substantial clinical, quality, and administrative resources.

The level of documentation and operational infrastructure needed to support affirmative reporting may disproportionately impact hospitals with limited staffing, including smaller, rural, and safety-net hospitals. These organizations may face challenges sustaining the personnel and data infrastructure necessary to meet measure requirements, even when meaningful sepsis improvement activities are occurring.

While we support the goal of promoting comprehensive sepsis programs, we encourage CMS to consider whether the current measure structure appropriately accounts for variation in hospital resources and capacity. Potential considerations include:

• Allowing greater flexibility in how hospitals demonstrate compliance with core elements;
• Phasing in requirements or prioritizing high-impact elements; and/or
• Providing clear sub-regulatory guidance to reduce documentation burden and promote consistent interpretation.

Without such considerations, there is concern that the measure may function more as a test of administrative capacity than of meaningful sepsis care improvement, potentially limiting its effectiveness and fairness across hospital settings.

I strongly urge CMS to advance and adopt the proposed sepsis structural and outcome measures. These measures are not just appropriate...They are urgently necessary.

My family experienced maternal sepsis following a stillbirth. Signs of sepsis began appearing within hours. Yet formal sepsis protocols were not initiated for nearly seven hours after those early warning signs. That delay was catastrophic. Sepsis does not wait, and when recognition is missed or action is delayed, mortality rises sharply.

The grief of losing a child to stillbirth was only compounded by having to bury her mother, my wife, as well. No family should have to experience loss caused by failures in recognition, escalation, and accountability. Nothing can bring my angels back, but we can and must prevent other families from walking this same path.

These proposed measures would directly address the system gaps that cost lives:

• requiring formal hospital sepsis programs
• standardizing early recognition and escalation
• mandating outcome tracking and transparency
• creating accountability for preventable sepsis deaths

Sepsis is already one of the leading causes of death in U.S. hospitals. Yet unlike other high-mortality conditions, it has lacked consistent, enforceable national standards. That gap has left too many families broken by deaths that were avoidable.

We need these measures in place because too many families and too many hearts have been broken by preventable sepsis deaths. CMS has the opportunity and the moral imperative to change that reality.

Please adopt and implement these sepsis measures without delay. Lives depend on it.

My wife passed away due to sepsis at the young age of 66 years on 3/1/2025. From the time she exhibited the first minor symptoms at home until I took her to the ER was 12 hours. From the time she arrived at the ER until her passing was 15 hours. The first hospital apparently did not recognize the seriousness of her condition and responded with no urgency in transferring her to the WRONG hospital. They too, were much too slow to recognize her condition and react. She passed while in route to the third hospital, where she should have been originally transferred, 12 hours before her passing. 

I am retired research microbiologist and member of the Sepsis Alliance Advisory Board. From my 26 years of experience in Pharma developing new antibiotics and vaccines to prevent the devasting impact of Sepsis pathogens, I welcome new policies that seek better outcomes for patients at risk of developing sepsis. 

It is vital that hospitals and insurance companies are held accountable for rigorous sepsis care structure and outcome measures such as risk-adjusted mortality and 30-day all-cause readmissions. However, these new proposed measures are important but not sufficient on their own. SEP-1 is the only nationally standardized process measure for sepsis and provides critical accountability. New structural and outcome measures should be adopted alongside SEP-1, not in place of it. Maintaining all three elements of measurement is essential to protecting patients and improving sepsis care nationwide. I urge those responsible for setting policy at the federal level to ensure that SEP-1 remains a core element of sepsis control policy.

Robert G.K. Donald Ph.D.

Thank you for soliciting public comments on these measures.  I am the Chief Quality Officer of Northwell Health, a 28-hospital health system in New York and Connecticut.

I am very much in support of this measure.  At Northwell, and many other large (and small) health systems, sepsis is one of our leading causes of inpatient mortality, for both community-acquired, and hospital-acquired sepsis.  We have implemented the CDC's core elements prior to their being published, and have seen a decrease in our mortality rates (for both community- and hospital-acquired sepsis).  These elements are extremely intuitive, are risk-free, and above all, drive the mission of continuous improvement (something that is at the core of my organization's culture).

My only ask would be to include this measure for pediatric sepsis as well.   An identical program was implemented several years ago by the Children's Hospital Association's Improving Pediatric Sepsis Outcomes (IPSO), a collaborative of more than 50 children's hospitals across the US, and as you would expect, the mortality for pediatric sepsis decreased during the course of the collaborative.  I understand from talking with Dr. Ronald Kline at a StopSepsis.org function in 2024 that this might be difficult to enforce/financially incentivize, but I ask that you take it into consideration.  The cost of sepsis - especially missed sepsis - in children is heartbreaking.

Feel free to reach out if I can be of further assistance.

I am a pulmonary/critical care physician who has cared for 1000s of sepsis patients.  I am also a board member of Sepsis Alliance.  

Sepsis is a medical emergency that requires timely recognition and treatment. Quality measurement must reflect structure, process, and outcomes.

I support the CDC Core Elements to assess sepsis care structure and outcome measures such as risk-adjusted mortality and 30-day all-cause readmissions. These measures are important but not sufficient on their own.

Process measures remain essential to ensure timely and appropriate care for individual patients. SEP-1 is the only nationally standardized process measure for sepsis and provides critical accountability.

New structural and outcome measures should be adopted alongside SEP-1, not in place of it. Maintaining all three elements of measurement is essential to protecting patients and improving sepsis care nationwide.

Jim O'Brien

Sepsis is a medical emergency that requires timely recognition and treatment. Quality measurement must reflect structure, process, and outcomes.

I support the CDC Core Elements to assess sepsis care structure and outcome measures such as risk-adjusted mortality and 30-day all-cause readmissions. These measures are important but not sufficient on their own.

Process measures remain essential to ensure timely and appropriate care for individual patients. SEP-1 is the only nationally standardized process measure for sepsis and provides critical accountability.

New structural and outcome measures should be adopted alongside SEP-1, not in place of it. Maintaining all three elements of measurement is essential to protecting patients and improving sepsis care nationwide.

I am writing to you as the father of Sam Terblanche, a 20 year-old student at Columbia University who died in his dorm room in September 2023 after he went to the emergency department of a leading New York hospital two nights in a row and triggered the hospital’s sepsis alert the second night.  He was discharged despite the hospital’s automated alert system initiating its sepsis alert after he presented with classic sepsis symptoms.  Like so many of the 350,000 annual sepsis deaths in the United States, Sam’s death was preventable.  We need better hospital systems, better process measures and better outcomes measures.  Critically, we need all three these conditions in place to fight sepsis in a meaningful way.

I come from a non-medical background, but with over 30 years extensive expereince on the regulation of time-sensitive, dangerous and complex industries such as nuclear safety, civil aviation, toll roads and telecommunications networks.  Compared to medicine, these industries have far superior customer (patient) safety records.  They succeed because they focus aggresively on their equivalent of hospital systems, process measures and outcomes measures.  In particular, they have superior process measures (their equivalent of SEP-1) because they understand that reliance on outcomes measures alone means they only investigate fallen planes and melted down nuclear reactors.  Put differently, reliance on outcomes measures in time-sensitive life-and-death industries means we often measure outcomes after the patient died.   That is too late.       

With the foregoing critical caveat, I support the CDC Core Elements to assess sepsis care structure and outcome measures such as risk-adjusted mortality and 30-day all-cause readmissions. These measures are important but not sufficient on their own.

Process measures remain essential to ensure timely and appropriate care for individual patients. SEP-1 is the only nationally standardized process measure for sepsis and provides critical accountability.  While SEP-1 itself may need to be updated and digitized in the near term, it saves thousands of lives and without it we could expect a catastrophic increase in preventable sepsis deaths.  

New structural and outcome measures should be adopted alongside SEP-1, not in place of it. Maintaining all three elements of measurement is essential to protecting patients and improving sepsis care nationwide.

Hi My name is Angela Craig MS,APN,CCNS,CCRN,CNMAP and I am a board member for Sepsis Alliance.  I have also worked with sepsis initiatives for many years.  I have seen the difference that having required elements for hospitals can make.  

Sepsis is a medical emergency that requires timely recognition and treatment. Quality measurement must reflect structure, process, and outcomes.

I support the CDC Core Elements to assess sepsis care structure and outcome measures such as risk-adjusted mortality and 30-day all-cause readmissions. These measures are important but not sufficient on their own.

Process measures remain essential to ensure timely and appropriate care for individual patients. SEP-1 is the only nationally standardized process measure for sepsis and provides critical accountability.

New structural and outcome measures should be adopted alongside SEP-1, not in place of it. Maintaining all three elements of measurement is essential to protecting patients and improving sepsis care nationwide.

Sepsis is a medical emergency that requires timely recognition and treatment. Quality measurement must reflect structure, process, and outcomes.

I support the CDC Core Elements to assess sepsis care structure and outcome measures such as risk-adjusted mortality and 30-day all-cause readmissions. These measures are important but not sufficient on their own.

Process measures remain essential to ensure timely and appropriate care for individual patients. SEP-1 is the only nationally standardized process measure for sepsis and provides critical accountability.

New structural and outcome measures should be adopted alongside SEP-1, not in place of it. Maintaining all three elements of measurement is essential to protecting patients and improving sepsis care nationwide.

Hi, my name is Jackie Duda and I’m a septic shock survivor https://www.washingtonpost.com/wellness/2023/09/16/sepsis-septic-shock-experience-near-death/. Sepsis is a medical emergency that requires timely recognition and treatment. Quality measurement must reflect structure, process, and outcomes.

I support the CDC Core Elements to assess sepsis care structure and outcome measures such as risk-adjusted mortality and 30-day all-cause readmissions. These measures are important but not sufficient on their own.

Process measures remain essential to ensure timely and appropriate care for individual patients. SEP-1 is the only nationally standardized process measure for sepsis and provides critical accountability.

New structural and outcome measures should be adopted alongside SEP-1, not in place of it. Maintaining all three elements of measurement is essential to protecting patients and improving sepsis care nationwide.

Thank you for your time. 
Jackie Duda 

As a critical care physician deeply involved with both caring for patients with sepsis as well as sepsis performance improvement, I strongly support ongoing CMS performance measures for sepsis.  They are a critical tool for helping drive quality improvement for sepsis and septic shock.  

Sepsis is a medical emergency that requires timely recognition and treatment. Quality measurement must reflect structure, process, and outcomes.

I support the CDC Core Elements to assess sepsis care structure and outcome measures such as risk-adjusted mortality and 30-day all-cause readmissions. These measures are important but not sufficient on their own.

Process measures remain essential to ensure timely and appropriate care for individual patients. SEP-1 is the only nationally standardized process measure for sepsis and provides critical accountability.

New structural and outcome measures should be adopted alongside SEP-1, not in place of it. Maintaining all three elements of measurement is essential to protecting patients and improving sepsis care nationwide.

Process measures remain essential to ensure timely and appropriate care for individual patients. SEP-1 is the only nationally standardized process measure for sepsis and provides critical accountability.

 

I am a practicing critical care and emergency medicine physician, physician leader, and a sepsis clinical researcher. With that background, I wholeheartedly appreciate that sepsis is a medical emergency requiring timely recognition and treatment.

Quality measurement must reflect structure, process, and outcomes, and I support the CDC Core Elements to assess sepsis care structure and outcome measures. These measures are important, however, they are insufficient in isolation. Process measures remain essential to ensure timely and appropriate care for individual patients.

As the only nationally standardized process measure for sepsis, SEP-1 provides critical accountability. New structural and outcome measures should be adopted in conjunction with SEP-1, but not as a substitute for it. Maintaining all three elements of measurement can be expected to best protect patients and improve sepsis care nationwide.

I'm a Member of the Board of Sepsis Alliance and a career diagnostics Expert who has worked on easily Sepsis Diagnostics and intervention. Sepsis is a medical emergency that requires timely recognition and treatment. Quality measurement must reflect structure, process, and outcomes.

I support the CDC Core Elements to assess sepsis care structure and outcome measures such as risk-adjusted mortality and 30-day all-cause readmissions. These measures are important but not sufficient on their own.

Process measures remain essential to ensure timely and appropriate care for individual patients. SEP-1 is the only nationally standardized process measure for sepsis and provides critical accountability.

New structural and outcome measures should be adopted alongside SEP-1, not in place of it. Maintaining all three elements of measurement is essential to protecting patients and improving sepsis care nationwide.

Sepsis is a medical emergency that requires timely recognition and treatment. Quality measurement must reflect structure, process, and outcomes.

I support the CDC Core Elements to assess sepsis care structure and outcome measures such as risk-adjusted mortality and 30-day all-cause readmissions. These measures are important but not sufficient on their own.

Process measures remain essential to ensure timely and appropriate care for individual patients. SEP-1 is the only nationally standardized process measure for sepsis and provides critical accountability.

New structural and outcome measures should be adopted alongside SEP-1, not in place of it. Maintaining all three elements of measurement is essential to protecting patients and improving sepsis care nationwide.

My name is Jackie Duda and I'm a member of the Sepsis Alliance Advisory Board. Four years ago, I nearly died from septic shock, https://www.washingtonpost.com/wellness/2023/09/16/sepsis-septic-shock-experience-near-death/ . 

Sepsis is a medical emergency that requires timely recognition and treatment. Quality measurement must reflect structure, process, and outcomes.

I support the CDC Core Elements to assess sepsis care structure and outcome measures such as risk-adjusted mortality and 30-day all-cause readmissions. These measures are important but not sufficient on their own.

Process measures remain essential to ensure timely and appropriate care for individual patients. SEP-1 is the only nationally standardized process measure for sepsis and provides critical accountability.

New structural and outcome measures should be adopted alongside SEP-1, not in place of it. Maintaining all three elements of measurement is essential to protecting patients and improving sepsis care nationwide.

Sincerely,

Jackie Duda

Sepsis is a medical emergency—every hour counts. As a physician and someone who lost a loved one to sepsis, I urge policymakers to maintain comprehensive measurement: structure, process, and outcomes. CDC Core Elements and outcome metrics like mortality and readmissions are vital, but they do not ensure timely care for individual patients.
 

Process measures remain essential. SEP-1 is the only national standard that holds hospitals accountable for rapid, appropriate treatment. Replacing SEP-1 would remove a critical safeguard.
 

New structural and outcome measures should complement SEP-1, not replace it. Keeping all three elements is the only way to protect patients and improve sepsis care nationwide.

As a Registered Nurse with over a decade of experience, including building several sepsis programs across the United States: I support the CDC Core Elements to assess sepsis care structure and outcome measures such as risk-adjusted mortality and 30-day all-cause readmissions. These measures are important but not sufficient on their own.

Process measures remain essential to ensure timely and appropriate care for individual patients. SEP-1 is the only nationally standardized process measure for sepsis and provides critical accountability.

New structural and outcome measures should be adopted alongside SEP-1, not in place of it. Maintaining all three elements of measurement is essential to protecting patients and improving sepsis care nationwide.

Warm regards

To Whom It May Concern,

I support CMS’s proposed sepsis readmission measure as a meaningful step toward reducing avoidable downstream utilization and improving continuity of care for patients with sepsis.

At the same time, as written, this measure functions as an unfunded mandate. It holds hospitals accountable for readmissions without providing a payment pathway for the diagnostic capability required to reduce them.

Sepsis readmissions are strongly influenced by diagnostic uncertainty at the initial encounter, particularly in the emergency department. Accurate early identification and risk stratification are essential to determining appropriate disposition, follow up, and escalation of care.

When hospitals lack diagnostic tools to confidently assess risk, they are more likely to admit low risk patients unnecessarily or discharge higher risk patients prematurely, both of which increase avoidable readmissions. Improving performance on sepsis readmission measures therefore depends directly on access to effective diagnostic capability.

Under current OPPS policy, many laboratory diagnostics used in sepsis evaluation, whether long standing or newly developed, are assigned Status Indicator Q4 (conditionally packaged) when billed in typical emergency department and outpatient encounters. These diagnostics are bundled into facility payments and not paid separately in the very settings where readmission critical decisions are made.

From a value perspective, paying for sepsis diagnostics is cost effective. Improved early diagnosis reduces unnecessary admissions, prevents missed high risk discharges, and generates meaningful gains in quality adjusted life years while reducing downstream costs.

If CMS intends this readmission measure to improve care rather than simply penalize hospitals, diagnostics used for sepsis evaluation should be unbundled. CMS should remove sepsis diagnostics from OPPS Q4 conditional packaging and allow separate payment when these diagnostics are used in emergency department and outpatient sepsis care.

I am a practicing clinician, a sepsis researcher, and the Chief Executive Officer of Inflammatix, a molecular diagnostics company focused on improving early identification and risk stratification of patients with suspected infection and sepsis. Inflammatix develops host response diagnostics intended to support clinical decision making at the point of care. My comments reflect experience in clinical practice, sepsis research, and the real world development and implementation of sepsis diagnostics.

Sincerely,

Tim Sweeney, MD, PhD
CEO, Inflammatix

As a septic shock survivor, Sepsis Alliance board member, multiple amputee from sepsis and patient advocate, this issue is extremely important to me. Sepsis is a medical emergency that requires timely recognition and treatment. Quality measurement must reflect structure, process, and outcomes.

I support the CDC Core Elements to assess sepsis care structure and outcome measures such as risk-adjusted mortality and 30-day all-cause readmissions. These measures are important but not sufficient on their own.

Process measures remain essential to ensure timely and appropriate care for individual patients. SEP-1 is the only nationally standardized process measure for sepsis and provides critical accountability.

New structural and outcome measures should be adopted alongside SEP-1, not in place of it. Maintaining all three elements of measurement is essential to protecting patients and improving sepsis care nationwide.

Sepsis is the #1 cause of hospital deaths in the U.S. and is the #1 cost of acute care. It is also the #1 cause for expensive and burdensome hospital readmissions with 40% of survivors requiring readmission within 90 days. Further, sepsis is the #2 cause of maternal mortality in the U.S., takes more children's lives than cancer, and disproportionately burdens our underserved communities across the nation. 

We have to do better.

Sepsis is a medical emergency that requires timely recognition and treatment. 

If we are going to be serious about reduce harm from sepsis, quality measurement must reflect structure, process, and outcomes.

I support the CDC Core Elements to assess sepsis care structure and outcome measures such as risk-adjusted mortality and 30-day all-cause readmissions. These measures are important but not sufficient on their own.

Process measures remain essential to ensure timely and appropriate care for individual patients. SEP-1 is the only nationally standardized process measure for sepsis and provides critical accountability. Research has show SEP-1 to be effective at saving lives without increasing the use of antimicrobials. Its addition to VBP will further secure its place as a critical component of sepsis care in the United States, and we look forward to continuing to revise and improve this measure as we continue to learn more about sepsis and we have more tools to assist it its diagnosis.

New structural and outcome measures should be adopted alongside SEP-1, not in place of it. Maintaining all three elements of measurement via these four measures is essential to protecting patients and improving sepsis care nationwide.

I lost my 8 month old Hadley Rae Fowle to Sepsis that was originally diagnosed as the flu. Given multiple different measures and protocols that were in placed, Hadley's symptoms were not on the "list" to introduce the Sepsis protocol or question " Could this be sepsis?"

I do know that if there was more time- sensitive measures that took place and more questions asked about if it could be sepsis, Hadley's life may have been saved. 

It's been 7 years since she passed from Klebsiella Oxytocca Bacteria infection that led to Sepsis. I have experienced multiple instances where it feels at times the hospitals and pediatric facilities have to be talked into checking if they have done blood work and are checking for sepsis with the severity of the illness. Is Sepsis top of mind? What if something is missed because of the measures in place and documentation needed. 

This is just one step to so many things that could improve the response time and current sepsis protocols. #HadleysLegacy

Hello, as a Registered Nurse for over 25 years and subject t matter expert for the sepsis population, the goal of care must be focused on delivery timely care by structured processes such as the Sep-1 bundle elements. 

Sepsis is a medical emergency that requires timely recognition and treatment. Quality measurement must reflect structure, process, and outcomes.

I support the CDC Core Elements to assess sepsis care structure and outcome measures such as risk-adjusted mortality and 30-day all-cause readmissions. These measures are important but not sufficient on their own.

Process measures remain essential to ensure timely and appropriate care for individual patients. SEP-1 is the only nationally standardized process measure for sepsis and provides critical accountability.

New structural and outcome measures should be adopted alongside SEP-1, not in place of it. Maintaining all three elements of measurement is essential to protecting patients and improving sepsis care nationwide.

Sepsis is a medical emergency that requires timely recognition and treatment. Following the highly respected Donebedian model framework, Quality measurement must reflect structure, process, and outcomes.

I support the CDC Core Elements to assess sepsis care structure and outcome measures such as risk-adjusted mortality. These measures are important but not sufficient on their own and complement SEP-1. Process measures remain essential to ensure timely and appropriate care for individual patients. SEP-1 serves as the only nationally standardized process measure for sepsis and provides critical accountability.

New structural and outcome measures should be adopted alongside SEP-1, not in place of it. Maintaining all three elements of measurement is essential to protecting patients and improving sepsis care nationwide.

As a clinician, educator, and healthcare leader, I have invested significant time and effort over the past three decades to improving screening, treatment, and outcomes management for sepsis.  Sepsis is a medical emergency that requires timely recognition and treatment. Quality measurement must reflect structure, process, and outcomes.

While I support the CDC Core Elements to assess sepsis care structure and outcome measures such as risk-adjusted mortality and 30-day all-cause readmissions, these important measures are not sufficient on their own.

Process measures remain essential to ensure timely and appropriate care for individual patients. SEP-1 is the only nationally standardized process measure for sepsis and provides critical accountability.

New structural and outcome measures should be adopted alongside SEP-1, not in place of it. Maintaining all three elements of measurement is essential to protecting patients and improving sepsis care nationwide.  

I support the new measures while maintaining SEP-1 through the Partnership for Quality Measurement process!  These are quality metrics that improve all of our lives.  

I support the CDC Core Elements to assess sepsis care structure and outcome measures such as risk-adjusted mortality and 30-day all-cause readmissions. These measures are important but not sufficient on their own.

Process measures remain essential to ensure timely and appropriate care for individual patients. SEP-1 is the only nationally standardized process measure for sepsis and provides critical accountability. Without it, we will continue to provide fragmented medical care to our patient populations. Hospitals across the nation will no longer be held accountable to ensure timely care is provided to sepsis patients.

New structural and outcome measures should be adopted alongside SEP-1, not in place of it. Maintaining all three elements of measurement is essential to protecting patients and improving sepsis care nationwide. With the addition of the structural and outcomes measures, SEP-1 elements should be examined and overhauled to align with HMS.

I have cared for many patients with sepsis and helped hospitals set up sepsis programs so that all patients with sepsis get the appropriate timely treatment.  I also have had many of my immediate family have sepsis and survived because they got the evidence based interventions (included in SEP-1)

Sepsis is a medical emergency that requires timely recognition and treatment. Quality measurement must reflect structure, process, and outcomes.

I support the CDC Core Elements to assess sepsis care structure and outcome measures such as risk-adjusted mortality and 30-day all-cause readmissions. These measures are important but not sufficient on their own.

Process measures remain essential to ensure timely and appropriate care for individual patients. SEP-1 is the only nationally standardized process measure for sepsis and provides critical accountability.

New structural and outcome measures should be adopted alongside SEP-1, not in place of it. Maintaining all three elements of measurement is essential to protecting patients and improving sepsis care nationwide.

 I  speak to you today as a sepsis survivor, the father of a 23-year-old daughter who died from septic shock after a hemorroidectomy, a brother who died from a UTI, and the Founder of the Sepsis Alliance.  I know professionally that lives are saved when sepsis is recognized early and treated with timely, evidence-based care.

Sepsis is a medical emergency. Delays of even hours lead to organ failure, amputations, cognitive decline, prolonged ICU stays, and death. Families are left with lifelong consequences—whether from loss, disability, or trauma—when timely care doesI know—personally and not happen.

That is why, how we measure sepsis care matters.

Quality measurement must include structure, process, and outcomes. I support the CDC Core Elements that assess sepsis care infrastructure and outcome measures such as risk-adjusted mortality and 30-day all-cause readmissions. These measures are essential—but they tell us only what happened after the fact.

Process measures ensure action in the moment. They help make sure that a patient with worsening vital signs or altered mental status receives timely antibiotics, fluids, and escalation of care when every hour matters. SEP-1 is currently the only nationally standardized sepsis process measure, and it provides essential accountability for bedside care—especially for patients who cannot advocate for themselves.

Weakening or replacing process measurement would have real consequences: more missed sepsis, more delayed treatment, more preventable organ failure, and more families facing outcomes that did not have to happen.

New structural and outcome measures should be adopted alongside SEP-1, not in place of it. Maintaining all three elements of measurement is essential to protecting patients and improving sepsis care nationwide.

Dear Committee Members,

I am a Critical Care Clinical Nurse Specialist (CNS) who has taken care of patients with sepsis and the associated complications of multiple organ dysfunction, post-ICU syndrome, and death. I have supported family members through weeks to months of sepsis-associated critical illness and the dying process. My son survived Staph Aureus sepsis from an infected blister on his foot when he was 6 years old -he was fortunate to survive after being misdiagnosed at urgent care and then hospitalised with 8 weeks of antibiotics. The delays and lack of awareness of paediatric sepsis were prior to the increased awareness due to CMS measures and the work of the Sepsis Alliance and sepsis advocate educators in our health care system.  I worked as an educator (clinical professor) and CNS in a large academic medical centre where I led evidence-based practice implementation (of process measures) in our hospital system that aimed at early identification of infection and sepsis, prevention of infection, and early evidence-based interventions to treat sepsis and related supportive care interventions to optimise patient outcomes, including reducing sepsis-associated morbidity and mortality.
Sepsis is a medical emergency that requires timely recognition and treatment. Quality measurement must reflect structure, process, and outcomes.
I support the CDC Core Elements to assess sepsis care structure and outcome measures such as risk-adjusted mortality and 30-day all-cause readmissions. These measures are important but not sufficient on their own.
Process measures remain essential to ensure timely and appropriate care for individual patients. SEP-1 is the only nationally standardized process measure for sepsis and provides critical accountability. 
New structure and outcome measures should be adopted alongside SEP-1, not in place of it. Maintaining all three elements of measurement is essential to protecting patients and improving sepsis care nationwide.

Thank you for your attention to this important health care focus for U.S. patients and their families. 

I am a sepsis survivor. I was hospitalized for 2+ months. My surgeons office told me that I probably had the flu. I was a nurse and knew what was going on was serious. My family practice physician started me on antibiotics which basically saved my life. 2 days later I was directly admitted to the hospital from my surgeons office. The aftercare from rehab was non existent. It permanently ruined my life as I knew it. The medical community needs to be required to educate themselves on recognition so there is prompt care, as well as post sepsis syndrome, which is a very real thing. I still have my symptoms 7 years later. Many survivors also have very real PTSD for the pain and horror they went through. Please help.

I support the proposed Core Elements Score in addition to SEP-1.  My daughter died at 26 from undiagnosed septic shock in 2021.  She had many telltale symptoms,  but did not have a high fever ;  therefore, in one of the most respected hospital systems in the world, her sepsis was overlooked and she died because antibiotic treatment was delayed.  By the time sepsis was suggested as a possible diagnosis, it was too late for her.  It is my opinion that if there was a non-weighted, objective score given to her symptoms, or a standard protocol based on those symptoms that included antibiotic therapy, she would be alive today.  Sepsis is such a common illness that it is nonsensical that a young, otherwise healthy person in the US can be displaying obvious symptoms and yet diagnosis can be elusive.  Please save other families the pain of having to endure such tragedy.

I am a septic shock survivor of 2024.  I had classic sepsis systems that were ignored by my HMO's advice line. The advice I was given nearly cost me my life and in the end cost me my hands and feet. 

Sepsis is a medical emergency that requires timely recognition and treatment. Quality measurement must reflect structure,process, and outcomes.

I support the CDC Core Elements to assess sepsis care structure and outcome measures such as risk-adjusted mortality and 30-day all-cause readmissions. These measures are important but not sufficient on their own.

Process measures remain essential to ensure timely and appropriate care for individual patients. SEP-1 is the only nationally standardized process measure for sepsis and provides critical accountability.

New structural and outcome measures should be adopted alongside SEP-1, not in place of it. Maintaining all three elements of measurement is essential to protecting patients and improving sepsis care nationwide.

My mother died of sepsis in a hospital in 2019.  If more had been done and it had been caught earlier and there had been gerater adherence to quality metrics, perhaps her death could have been prevented. 

Sepsis is a medical emergency that requires timely recognition and treatment. As someone who has spent three decades in health policy and am a former measure developer, I know that quality measurement must reflect structure, process, and outcomes.

I support the CDC Core Elements to assess sepsis care structure and outcome measures such as risk-adjusted mortality and 30-day all-cause readmissions. These measures are important but not sufficient on their own.

Process measures remain essential to ensure timely and appropriate care for individual patients. SEP-1 is the only nationally standardized process measure for sepsis and provides critical accountability.

New structural and outcome measures should be adopted alongside SEP-1, not in place of it. Maintaining all three elements of measurement is essential to protecting patients and improving sepsis care nationwide.

Having had a mother suffer from sepsis twice, countless colleagues and friends suffer from sepsis as well as working in mortality improvement work for a national healthcare performance improvement organization, I have a personal relationship with sepsis and efforts to improve outcomes for us all. 

Sepsis is a medical emergency that requires timely recognition and treatment. Quality measurement must reflect structure, process, and outcomes.

I support the CDC Core Elements to assess sepsis care structure and outcome measures such as risk-adjusted mortality and 30-day all-cause readmissions. These measures are important but not sufficient on their own.

Process measures remain essential to ensure timely and appropriate care for individual patients. SEP-1 is the only nationally standardized process measure for sepsis and provides critical accountability.

New structural and outcome measures should be adopted alongside SEP-1, not in place of it. Maintaining all three elements of measurement is essential to protecting patients and improving sepsis care nationwide.

Sincerely, 

Shannon Hale

The Selective Cytopheretic Device stops Sepsis.

As a survivor of sepsis , it is imperative that hospitals have better protocols in evaluating for sepsis. I was turned away at the ER 1 week prior to falling into sepsis shock . If the hospital had truly taken the time to evaluate my case they would have seen I had MRSA . Within 5 days I was in a coma being rushed back to the same hospital. My organs failing, pneumonia and  a blood clot. 
Thank god my husband found me unresponsive in the early morning hours or I wouldn’t be alive. I took all the proper channels. I went to my primary care doctor, went to the ER both missed the opportunity to discover what was happening to me . Routine bloodwork would have shown something. We need to do better . We need emergency protocol to avoid people going into sepsis shock. 
It was 2 year journey to get my health back. To think that my first visit to the ER could have played out differently and spared me and my family going through the trauma of sepsis is frustrating . I presented all the signs. 4 hospitals later 3 rehabs and a multitude of Doctors that I am forever , I will always be haunted at the what if… what if they had just kept me in the hospital for a couple of days to figure out what is making me so sick. What if my primary had insisted on further bloodwork?. What if in the ambulance they had started me on sepsis antibiotics protocol. Either way it wouldn’t have hurt . We need to do better . Sepsis is dangerous, deadly and can be treated when recognized early or the potential is . 

I am in agreement with the implementation of the CMS Hospital Sepsis Program. I know firsthand how Severe Sepsis can impact lives, and takes lives abruptly and the scariest part of it all is when hospital staff don’t recognize the signs and symptoms of a patient who is in distress from sepsis. Time is of the essence and be a matter of life or death if not caught in time. But also the post impacts of sepsis to patient is just a critical. This is why we need every ounce of support to combat the deadly effects of Sepsis. I am total agreement with all of the implications and strategies presented . 

On behalf of Sepsis Alliance, the nation’s leading nonprofit organization dedicated to saving lives and limbs from sepsis, we appreciate the opportunity to comment on CMS’s approach to sepsis quality measurement. We represent millions of sepsis survivors, caregivers, and families, and work closely with clinicians and policymakers to improve sepsis care across the country.

The quality improvement framework established by Avedis Donabedian emphasizes three essential components of high-quality care: structure, process, and outcomes. Sepsis Alliance supports the CDC Core Elements as an effective framework for measuring the structure of sepsis care, and we endorse the proposed outcome measures of risk-adjusted mortality and 30-day all-cause readmissions, with minor refinements.
 

However, structural and outcome measures alone are insufficient. They do not assess the processes of care delivered to individual patients, which are critical in a time-sensitive condition such as sepsis. These measures cannot replace SEP-1, which remains the only nationally standardized process measure holding hospitals accountable for timely and appropriate sepsis care.

Sepsis Alliance strongly supports adoption of the proposed structural and outcome measures alongside SEP-1, not in place of it. Maintaining all three domains of measurement is essential to ensure accountability, consistency, and continued improvement in sepsis care. If CMS adopts and sustains this comprehensive approach, it will be fulfilling its duty to the American public.

As a long standing advisory board member of the Sepsis Alliance, I am incredibly committed to ensuring hospitals and other institutions are delivering timely patient care to prevent sepsis-associated morbidity and mortality. 

As many are aware, sepsis is a medical emergency that requires timely recognition and treatment. Quality measurement must reflect structure, process, and outcomes, which are integral to any quality improvement initiative.

I support the CDC Core Elements to assess sepsis care structure and outcome measures such as risk-adjusted mortality and 30-day all-cause readmissions. These measures are important but not sufficient on their own.

Process measures remain essential to ensure timely and appropriate care for individual patients. SEP-1 is the only nationally standardized process measure for sepsis and provides critical accountability.

New structural and outcome measures should be adopted alongside SEP-1, not in place of it. Maintaining all three elements of measurement is essential to protecting patients and improving sepsis care nationwide. 

Warm Regards during this holiday season,

Frankie Hamilton

Vice President of Nursing Operations 

My mother wasn’t into Septic Shock in July of 2018, thankfully she survived thanks solely to her care team in the hospital. My father died from Septic Shock in March of 2023, his care them did all they could to treat him but unfortunately he was not strong enough to overcome.

Sepsis is a medical emergency that requires timely recognition and treatment. Quality measurement must reflect structure, process, and outcomes.

I support the CDC Core Elements to assess sepsis care structure and outcome measures such as risk-adjusted mortality and 30-day all-cause readmissions. These measures are important but not sufficient on their own.

Process measures remain essential to ensure timely and appropriate care for individual patients. SEP-1 is the only nationally standardized process measure for sepsis and provides critical accountability.

New structural and outcome measures should be adopted alongside SEP-1, not in place of it. Maintaining all three elements of measurement is essential to protecting patients and improving sepsis care nationwide.

New structural and outcome measures should be adopted alongside SEP-1, not in place of it. Maintaining all three elements of measurement is essential to protecting patients and improving sepsis care nationwide.

I support the CDC Core Elements to assess sepsis care structure and outcome measures such as risk-adjusted mortality and 30-day all-cause readmissions. These measures are important but not sufficient on their own.

 

Hello,

My mother passed of sepsis and left me to raise my two younger siblings.  Please, start the new measures while maintaining SEP-1 through the Partnership for Quality Measurement process. Thank you.

This score is a step in the right direction for improving sepsis care across the spectrum. A key to the success of the measure is to ensure flexibility in its implementation and further refinement of the metrics measured to ensure compliance is truly associated with improved outcomes for patients. 

The CDC's Hospital Core Elements program represents a vital component of providing excellent sepsis care, and we strongly support its implementation. However, as a Core Measure for CMS, this is very poorly written. There are no metrics attached other than that a hospital's NHSN reporting team answers a survey. The survey is not given, levels of compliance are not specified, and there are no objective means of corroborating survey answers. We believe that the measure needs to be better specified before it can be supported or before it should be adopted. Again, we strongly support the concept. 

I write on behalf of Blue Spark Technologies to express strong organizational support for the Centers for Medicare & Medicaid Services’ (CMS) proposed sepsis quality measures currently released for public comment. These measures represent a pivotal opportunity to standardize structural requirements and outcome accountability for sepsis care across the United States and align with evidence-based practices shown to improve patient outcomes.

Blue Spark Technologies strongly supports the proposed structural measure, the Hospital Sepsis Program Core Elements Score, which would require hospitals nationwide to implement and sustain sepsis programs based on the CDC’s Hospital Sepsis Program Core Elements framework. This framework promotes early recognition, evidence-based treatment, recovery support, and systematic outcome monitoring—elements substantiated to reduce mortality, decrease length of stay, and lower healthcare costs.

We also strongly support the proposed outcome measures, including:

• Adult Community-Onset (CO) Sepsis Standardized Mortality Ratio (SMR)
• Hospital 30-Day, All-Cause, Risk-Standardized Readmission Rate (RSRR) Following Sepsis Hospitalization

Outcome measures are essential to objectively assess whether care is effective, reveal performance gaps, inform improvement strategies, and ensure accountability. These measures will provide robust, risk-adjusted data to track hospital performance over time and align sepsis care with established CMS outcome reporting frameworks.

Blue Spark Technologies develops and deploys technology-enabled clinical solutions that improve early detection and management of sepsis and other time-sensitive conditions. For example, continuous temperature monitoring integrated with clinical workflows enable earlier identification of fever and physiologic deterioration compared with intermittent spot checks. Early fever detection has been associated with earlier intervention and improved outcomes in high-risk populations at risk for sepsis: https://www.cell.com/cancer-cell/pdfExtended/S1535-6108(21)00398-6).

Our experience in hospital environments demonstrates continuous monitoring:

• Enhances early recognition of sepsis triggers, including subtle temperature changes that may precede clinical deterioration.
• Improves clinician situational awareness through automated alerts and integration with electronic health records.
• Supports adherence to evidence-based protocols by providing timely data to guide sepsis screening, escalation, and documentation.

These technology-enabled capabilities directly support the goals of the proposed structural measure by operationalizing core elements of early recognition and timely intervention and providing data streams essential to the proposed outcome measures. Widespread adoption of structural sepsis programs that incorporate continuous monitoring technologies will strengthen hospitals’ ability to achieve measurable improvements in sepsis outcomes.