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. Author manuscript; available in PMC: 2025 Nov 1.
Published in final edited form as: Semin Perinatol. 2024 Sep 19;48(7):151976. doi: 10.1016/j.semperi.2024.151976

CMQCC Obstetric Sepsis Toolkit Update: A patient-centered approach to quality improvement

Elliott K Main 1, Ruhi Nath 1, Melissa E Bauer 2
PMCID: PMC11568914  NIHMSID: NIHMS2024225  PMID: 39358161

Abstract

Obstetric sepsis is a leading cause of maternal mortality and severe maternal morbidity in the United States. However, it is uncommon, and diagnosis and treatment are often delayed. This report summarizes recent work to develop a patient-centered approach for the care of patients with obstetric sepsis. To support patients, educational materials to identify warning signs paired with advocacy tips are important. Following an adverse event, outlines and checklists for patient support are provided. These tools have been developed to address a variety of obstetric conditions and have utility beyond sepsis. On the clinical side, new data to establish a standardized approach to screening and diagnosis is covered in detail. This “two-step” approach has been supported by national obstetric organizations and has similarities to the algorithm used to screen neonates for term early onset sepsis. In addition, the approach for implementation of a sepsis care bundle by the California/Michigan Obstetric Sepsis Quality Collaborative is discussed.

Introduction

The California Maternal Quality Care Collaborative was founded in 2006 with the mission to end preventable maternal mortality and morbidity. As a foundation for this effort, we used our experiences leading the California Pregnancy Associated Mortality Review Committee and our analysis of near real-time linked maternal-neonatal data sets to establish a series of state-wide quality improvement (QI) collaboratives.1 Our philosophy from the outset was “data to action”, with large-scale QI efforts for Obstetric Hemorrhage, Maternal Hypertension, and Supporting Vaginal Birth (reducing primary cesarean delivery).2 Each of these efforts was preceded by the development of comprehensive multi-disciplinary QI Toolkit to provide resources for hospitals and clinicians to drive improvement. In 2020 we identified obstetric sepsis as an important topic and we developed a widely respected “Improving Diagnosis and Treatment of Maternal Sepsis” Toolkit that focused on screening, diagnosis, and treatment.3 However, the evidence base was not as robust as we desired as many of the recommendations for screening were consensus based and we wanted to offer a more community and patient-centered approach. Therefore, we delayed undertaking a large-scale QI collaborative until the evidence base could be improved. Much has changed in the ensuing 4 years. The Alliance for Innovation on Maternal Health (AIM) based at the American Association of Obstetricians and Gynecologist (ACOG) released a national Safety Bundle on Sepsis in Obstetric Care in 2023.4 The Society for Maternal Fetal Medicine published a clinical consult series also in 2023.5 At the same time together working with Dr Melissa Bauer and her colleagues at the Michigan AIM QI Collaborative we embarked on an NICHD funded project to fill in the missing pieces from both clinical and patient-centered perspectives.6

Throughout this discussion we will use two related terms, obstetric sepsis and maternal sepsis. “Obstetric sepsis” is useful as it specifically includes cases beyond birth and is more inclusive. It refers the diagnosis of sepsis of any cause (including non-obstetric causes) from conception through the postpartum period. However, much of the literature refers to “maternal sepsis” and we may cite the original terminology, when appropriate.

Sepsis is currently the second most common cause of maternal death in the United States; delays in care lead to 63% of these preventable deaths and early recognition remains the major challenge in the path to prevention.7 Furthermore, is the 3rd most common cause of severe maternal morbidity. So why are we doing so poorly with Obstetric Sepsis? After all, protocols for the treatment of sepsis are well established and do not differ appreciably in pregnancy. Our first step was to identify patient barriers to obstetric sepsis care. We interviewed sepsis survivors and family members who identified several fundamental issues: 1) Patients and family members did not know the signs and symptoms of sepsis (or even what the term sepsis means); 2) patient complaints are often dismissed; 3) When dismissed, patients did not know how to best advocate for themselves.8 Maternal mortality reviews have identified several key clinical issues.9,10 Screening approaches and diagnostic criteria are not standardized. This results in delayed recognition and treatment. Furthermore, sepsis is relatively rare contributing to delays in recognition. In this article we describe our efforts to address these challenges in the setting of a two-state obstetric sepsis quality improvement collaborative in California and Michigan. Before we began the clinical initiative, we spent two years collecting large data sets and developing patient-centered resources to address these issues. First, we will address the basic clinical issues.

Defining Sepsis in Pregnancy

The definition of adult sepsis has continued to evolve over the past three decades. In 1992, A multi-organizational consensus panel developed the first standardized definition of sepsis as infection plus evidence of systemic inflammatory response syndrome (SIRS).11 Severe sepsis was defined as organ dysfunction. This remained unchanged in 2002 following a second consensus panel. New data led to a third consensus panel in 2016 (Sepsis-3) which revamped the definition of sepsis to Infection plus end-organ injury and discarded SIRS as a criterion.12 In the setting of pregnancy, SIRS has proven unsatisfactory. For example, in >90% of patients with chorioamnionitis meet the standard adult SIRS criteria.13 In 2017, WHO declared that maternal sepsis should be defined as infection plus end-organ injury and specifically stated that SIRS should not be used to define maternal sepsis.14 The American College of Obstetricians and Gynecologists (ACOG) and the Society of Maternal Fetal Medicine (SMFM)5 and the CDC15 have recently defined maternal sepsis as infection with end-organ injury. Furthermore, the CDC stated that obstetrics should be considered a special population akin to pediatrics for reporting.15 CMS remains the only major organization that is continuing to use infection plus SIRS to define obstetric sepsis in their National Hospital Inpatient Quality Measures, Severe Sepsis and Septic Shock Early Management Bundle ( SEP-1).16

Refinement of the Two-Step Screening Tools for Obstetric sepsis

In 2020, CMQCC’s “Improving Diagnosis and Treatment of Maternal Sepsis” Toolkit3 introduced a two-step screening approach using a pregnancy adjusted SIRS first step followed by testing for end-organ injury to complete the diagnosis. Recently, we published two large studies examining the first step using a range of criteria including SIRS, Maternal Early Warning Criteria (MEWC), Maternal Early Warning Trigger Tool (MEWT) and CMQCC and UKOSS pregnancy adjusted SIRS.17,18 Electronic Health Record (EHR) data for intrapartum, antepartum and postpartum patients from 71 hospitals and covering a population of an estimated 600,000 patients to identify sepsis cases. Using CMQCC and UKOSS criteria as the first step were superior with much lower false positive rates and similar sensitivity. As obstetric sepsis has a low incidence, despite the reasonable specificity of the CMQCC screen, the positive predictive value was too low to serve as the definitive diagnostic step. Thus, we recommend a second step of testing for end-organ injury within this enriched population. This two-step approach has been endorsed by SMFM5 and by an editorial in Obstetrics and Gynecology accompanying the research studies entitled, “Finding the needle in the haystack.”19 Indeed, a two-step approach is commonly used for other rare conditions familiar to Obstetricians/Gynecologists. For example, to diagnose syphilis we typically start with a VDRL as a first step screen and follow with a treponemal specific study (FTA, TP-PA, EIA) to confirm the diagnosis. Similarly, we screen for cervical cancer first using HPV/Pap smear testing followed with a cervical biopsy to make the diagnosis.

A criticism of defining sepsis as infection plus end-organ injury is that it may delay aggressive treatment until end-organ injury is already present. In the 2024 revision of the CMQCC Screening Flow Chart (Figure 1),20 we identify those with infection with an abnormal vital sign screen as “serious infection” and call for immediate antibiotics and a modest fluid challenge while sending laboratory tests for end-organ injury (Complete Blood Count and Comprehensive metabolic panel) and infection severity (Lactic acid level unless in second stage labor). This ensures rapid treatment and a balance of cost and yield for identifying those with end-organ injury. The algorithm is presented in Figure 1 and has been supported by the SMFM consensus report5 and the Obstetrics and Gynecology editorial.19 Language is important and in the 2024 revision of the Screening Flow Chart, we are careful to label the first step as a screen for “serious infection” and refrain from using the word sepsis until end-organ injury is confirmed. This avoids language in the chart such as “Sepsis screen positive” which often could get coded with the diagnosis of sepsis. In our QI collaboratives we have noted some hospitals using the older sepsis definition of infection with SIRS had 3–4 times the rate of ICD-10 codes for “sepsis” as state average. Since obstetric sepsis is a key part of the composite Severe Maternal Morbidity metric, these hospitals are then outliers for the now publicly reported CMS measure.

Figure 1.

Figure 1.

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The 2024 Revised CMQCC Obstetric Serious Infection / Sepsis Evaluation Flow Chart

It should be noted that fever is not required to diagnose obstetric infections or sepsis. Indeed, an important finding in a study of maternal deaths from sepsis was that 73% of patients who died from sepsis presented with temperatures in the normal range and 25% never developed a fever.10,21 Lack of fever may have led to delays in recognition and treatment.10 Attention to other vital signs and listening to patient’s symptoms may prevent such cases from being overlooked. Similarly, ACOG has recently released guidance that fever is not required for the diagnosis of intrauterine infection/chorioamnionitis in the setting of other signs and symptoms.22

A key element in the two-step approach for screening and diagnosis of obstetric sepsis is the bedside evaluation following a positive first step screen. This evaluation includes a brief clinical evaluation and history and can be done by any level of clinical (MD/DO, CNM, or RN). This evaluation addresses three simple questions: is there a likelihood of infection? Is there an alternative diagnosis of preeclampsia or hemorrhage that explains the abnormal vital signs? Does the patient have sepsis symptoms or is seriously ill appearing? This is the same approach taken in the Kaiser Neonatal Early Onset Sepsis Calculator for the evaluation of newborns following maternal chorioamnionitis.23 Notably early onset sepsis in term babies has a similar low incidence (1–3 per thousand) to obstetric sepsis. In the Kaiser algorithm after inputting a variety of clinical data points about labor, the next step is a clinical exam of the infant and if the baby is not clinically ill there is enhanced observation. This last set of activities has been observed, after detailed review, to be the most impactful part of the algorithm.24 These steps are mirrored in the CMQCC Obstetric Serious Infection /Sepsis Evaluation Flow Chart by the call for the bedside evaluation and enhanced maternal surveillance.

Patient Centered Approach to Severe Maternal Events

A key action in planning for our two-state Obstetric Sepsis Collaborative was to develop a Community Leadership Board as an equal partner to guide each step of the project from planning through implementation.6 The Board included patients with lived experience and persons with backgrounds in public health, patient advocacy and community leaders. The importance of collaboration between community partners and individuals with lived experience to address obstetric sepsis is absolutely vital to the design and implementation of relevant, impactful interventions aimed at reducing obstetric sepsis. Research suggests that community-engaged approaches can enhance the effectiveness of health interventions and improve maternal health outcomes by ensuring that research addresses the real needs and concerns of those most affected – patients and their support systems. The most effective strategies are informed by patient stories, understanding the physical and psychological trauma birthing persons endure during an SME and working to design improved experiences. Specifically for this project, the Community Leadership Board co-developed the guides for the patient and clinical interviews. These interviews identified the need for patient-centered resources and interventions which in turn were co-designed by the Board. Early on we realized that these resources were applicable beyond obstetric sepsis for most severe maternal events (SME). Key resources to address these challenges are presented below.

Patient Education for signs and symptoms of severe maternal events:

The Board identified two promising options: 1) Urgent Maternal Warning Signs.25 This was developed by the multidisciplinary Council on Patient Safety based at ACOG and is also promoted by the CDC Hear Her campaign (Figure 2). It is freely accessible at https://saferbirth.org/aim-resources/aim-cornerstones/urgent-maternal-warning-signs-2/, identifies 15 key signs and is available in 60 languages. For English and Spanish and soon other languages it has two additional levels of information by clicking on each warning sign. It is useful for antenatal, intrapartum and postpartum education and can help identify a wide range of severe maternal events. 2) The second option is the AWHONN POST-BIRTH Warning Signs.26 This graphic focuses on 9 key symptoms in the postpartum period that are either emergencies or need urgent attention. It is primarily used for predischarge education and is also available in over 20 languages. It is available as posters or kitchen magnets at the AWHONN website for a modest cost. https://www.awhonn.org/education/hospital-products/post-birth-warning-signs-education-program/

Figure 2.

Figure 2.

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Alliance for Innovation on Maternal Health (AIM)-Urgent Maternal Warning Signs (2024).

Advocacy Tips for Patients:

A repetitive theme from patient interviews was a strong feeling of not being heard or taken seriously. There was an intense desire for a resource that taught patients and their families how to speak up for themselves in medical conversations. For clarity, we are acknowledging that as health care professionals we need to listen better and this tool is provided as a resource in the interim and does not suggest patients need to advocate to get the care they deserve. In response, the Community Leadership Board co-developed an educational one-page document that provides example phrasing and advocacy tips for effective communication (Figure 3).27 This is available to freely download at: https://www.cmqcc.org/resources-toolkits/toolkits/improving-diagnosis-and-treatment-maternal-sepsis

Figure 3.

Figure 3.

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Patient self-advocacy language and tips to avoid dismissal.

Warning Signs Follow-up Guide for Providers:

Ensuring good communication requires education for both patients and clinicians. Many patients called in with symptoms but were met with reassurance that symptoms were typical of pregnancy or postpartum. This dismissal led to significant delays in recognition and treatment. This one-page document provides clinicians and office staff who triage phone calls with follow up questions and action steps to ensure that the patient is heard and appropriate decisions are made by the clinician to address the patients’ concerns.28 This is available to freely download at: https://www.cmqcc.org/resources-toolkits/toolkits/improving-diagnosis-and-treatment-maternal-sepsis and https://sites.google.com/miaim.us/miaim/advocacy-materials/provider-materials.

Resources for Patients after a Severe Maternal Event (SME):

Research indicates that experiencing a SME like sepsis or an ICU admission increases the risk for developing PTSD as well as other mental health conditions postpartum.29,30 A patient’s expected outcome for their birth often lies in stark contrast to their experience of almost dying, making this reality difficult for most to comprehend. Many patients report leaving the hospital with no clear understanding about the events of their birth, which can lead to further confusion and feelings of isolation, compounding symptoms of trauma. Not all trauma within the context of severe maternal events can be prevented, but it can be mitigated through compassion, acknowledgement, and detailed care discussions. Pre-discharge care discussions play a crucial role in trauma-informed care for patients following a severe maternal event. One of the most common concerns from patients after experiencing a traumatic birth is that they do not fully understand what happened during their birth. We strongly recommend that health care providers take the time to meet with patients who have experienced a severe maternal event to ensure a thorough understanding of what occurred, address any questions or concerns, and plan ongoing care. By offering a care discussion, patients gain a clearer understanding of their treatment and have the opportunity to ask questions. Care discussions not only offer information, but for many patients, they provide a starting point for their physical and emotional healing after an SME. Ideally, communications would begin immediately after an event, but the patient may not be fully receptive at that point. Our patient advocates recommend that a more formal session as described occur before discharge with key inpatient providers. It is optimal to have continuing discussions during outpatient care.

We developed a series of practical community and patient co-developed resources to aid communication and start the process of healing following a SME.31 These include: 1) a guide of what words not to use and alternatives; 2) a guide (with checklist) for how to do a Pre-discharge Care Discussion (also known as a patient care debrief) (see Figure 4); and 3) a checklist for post-discharge care following a SME identifying the range of follow-up services needed with a special emphasis on mental health.

Figure 4.

Figure 4.

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An example guide for a pre-discharge care discussion following a Severe maternal event.

California/Michigan Obstetric Sepsis Collaborative

As the tools and resources described above were completed, we launched a large-scale QI collaborative that involved multiple organizations in Michigan and California. Partners included professional organizations (e.g. state affiliates of ACOG and AWHONN), hospital system, hospital associations, public health departments, sepsis patient advocacy groups, community organizations and patients with lived experience of obstetric sepsis. First meetings were held in November 2023, with both states utilizing a novel approach to the CMQCC mentorship model. Traditionally, the Mentor Model of Collaborative Improvement involves pairing a group of 6–8 healthcare facilities with experienced physicians and nurses serving as mentors or coaches to facilitate exchange of resources, ideas and strategies to overcome barriers, and implementation lessons.32 This traditional approach has demonstrated success in improving maternal care quality, patient safety and a significant reduction in racial disparities in severe maternal morbidity for hemorrhage and reducing first birth cesarean deliveries.33,34 Building upon the effectiveness of this mentor model and emphasizing the importance of centering patient voice, the Sepsis Collaborative added both patient and community mentors for a total of four mentors per group. Patient mentors have been able to bring lived experience of their own severe maternal events (SME) and community mentors (who work in diverse settings such as public health departments, foundations, community-based organizations, and community leaders) provide advice as how to engage more broadly with the communities that we serve. Through this model, hospital clinical staff have the opportunity to engage with the perspectives of patients and local community leaders allowing for direct input into the revision of clinical practices. Over the course of twelve months, content was divided in quarterly blocks. In month 1, a webinar is provided to all participants on a set of clinical and patient centered topics, highlighted by a patient story. In month 2, mentor groups meet in their small groups to discuss implementation barriers and strategies centering the clinical topic. In month 3, mentor groups meet to discuss implementation barriers and strategies centering the patient focused topic. Each monthly meeting is facilitated by a set of four mentors – two clinical providers, a patient mentor and a community mentor. During these meetings every participating site “reports-out” on their progress in implementing MI AIM and CMQCC’s structure and process measures, designed to evaluate each site’s improvement over the course of the Collaborative.

Additional implementation strategies included saturation sharing of the patient education tools. The Urgent Maternal Warning Signs were printed as posters with hospitals placing them in Triage units, Antepartum Testing Units, Labor rooms, Neonatal Intensive Care Units, and in doctor’s exam rooms (OB-GYN and pediatricians). Other hospitals gave them out at every antepartum and postpartum discharge, others have incorporated them into their electronic communications so they are sent to patients at several key points during the pregnancy. Posters were printed in a variety of languages depending on the hospital clientele. In some sites, there was an emphasis on placing the Urgent Maternal Warning Signs as a bookmark on the patient and families’ smart phone. Our community partners are determining the best locations to post these documents in the community. Advocacy Tips were shared in a similar fashion.

The CMQCC Toolkit “Improving Diagnosis and Treatment of Maternal Sepsis” is undergoing revision to incorporate all of the topics discussed in this report. All of the resources mentioned here including the Webinars and slide sets, are available at https://www.cmqcc.org/resources-toolkits/toolkits/improving-diagnosis-and-treatment-maternal-sepsis.

We consider this a model of approaching a severe morbidity in a patient centered manner. The tools created during the two phases of this project (resource development and large scale-implementation) are available for all to modify and use in their own environments.

Funding Support

Research reported in this publication was supported by the Eunice Kennedy Shriver National Institute of Child Health & Human Development of the National Institutes of Health under Award Number UH3HD108053. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

Footnotes

Disclosures

The authors have no conflicts of interest.

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