The Performance Gap
Sepsis is a growing threat worldwide. The U.S. Centers for Disease Control and Prevention have reported that sepsis cases have increased in the U.S. from 621,000 in the year 2000 up to 1,141,000 in 2008.\cite{sepsis1} According to the World Sepsis Day Newsletter, “Preventing infections and fighting Sepsis to save 800,000 lives each year.”\cite{sepsis2} At least 10 to 15% of sepsis deaths are avoidable by: vaccination, hygienic measures, early detection, and prompt treatment measures. Hospitals and healthcare institutions need to do all that is practicable to eliminate hospital-acquired infections.
Sepsis is the most common cause of death in U.S. hospitals and nearly 15% of all sepsis deaths are preventable. Severe sepsis is estimated to affect 750,000 people annually in the U.S. and the infection has a 28.6 percent mortality rate. It kills more people than stroke and pneumonia.2 Nationally, mortality rates for sepsis cases entering the hospital through the emergency department range from 20 percent to more than 50 percent.\cite{schell2014reducing} Sepsis is a clinical syndrome with a continuum of increasingly severe manifestations. While a unified definition of sepsis remains in evolution, the term refers to the body’s response to an infection that has moved beyond localized tissue to become systemic inflammatory response syndrome (SIRS). In SIRS, signs and symptoms result from systemic activation of the immune response to an infection or an injury (such as trauma or acute pancreatitis). SIRS manifestations include tachycardia, tachypnea or hyperventilation, body- temperature changes, and leukocytosis or leukopenia.3 Unless identified and treated early, sepsis can progress to severe sepsis, which is defined by the presence of end organ dysfunction or tissue hypo-perfusion. Septic shock, at the far end of the sepsis continuum, is defined by persistent hypotension even after fluid resuscitation.
Early detection of sepsis, with the timely administration of appropriate fluids and antibiotics, appear to be the single most important factors in reducing morbidity and mortality from sepsis. It has become increasingly apparent that there is a long delay in both the recognition of sepsis and the initiation of appropriate therapy in many patients. This translates into an increased incidence of progressive organ failure and a higher mortality. Healthcare providers, therefore, need to have a high index of suspicion for the presence of sepsis and must begin appropriate interventions quickly. Early treatment of sepsis, severe sepsis, or septic shock with quantitative fluid resuscitation has been shown to improve patient outcomes in multiple studies,\cite{11794169,20069275} as has early treatment with antibiotics; however, to attain the greatest benefit from these therapies, sepsis must be identified as early as possible in its course. Multiple instruments have been developed to screen for sepsis.\cite{Kumar_2006,Ferrer_2009,Castellanos_Ortega_2010}
The Evaluation for Severe Sepsis Screening Tool, developed by the Surviving Sepsis Campaign and the Institute for Healthcare Improvement, consists of several components:\cite{sepsis9}
- A suspected or confirmed infection: checklist of common sites of infection
- Signs/symptoms of SIRS: temperature >38.3°C or <36°C, heart rate >90 beats/min, respiratory rate >20 breaths/min, acutely altered mental status, white blood cell count >12,000 μL (or 12 K/μL) or <4000 μL (or 4 K/μL)
- Signs of organ dysfunction/tissue hypoperfusion: systolic blood pressure <90 mmHg or decrease >40 mmHg from baseline, mean arterial pressure <70 mmHg, pulmonary infiltrates with increasing oxygen requirements to maintain SpO2 >90%, creatinine >2.0 mg/dL, bilirubin >2 mg/dL, platelet count <100,000/μL (or 100 K/μL), coagulopathy, or lactate >2 mmol/L
- Decrease in urine output and skin changes (mottling) or prolonged capillary-refill time.
A team approach is essential to developing a protocol for sepsis identification and treatment in the patient care unit/department/hospital. Early intervention in sepsis has been found to improve patient outcomes and mortality rates, but relies on completion of screening for rapid identification and communication of the results to the team members who can initiate appropriate treatments. It is the care delivered by the multidisciplinary team that is effective in improving patient outcomes.
Leadership Plan
The plan should include fundamentals of change outlined in the National Quality Forum safe practices, including awareness, accountability, ability, and action.7
- Identify: Hospital governance and senior administrative leadership must commit to become aware of their current performance regarding early detection and early appropriate management in their own healthcare system.
- A questionnaire has been developed so that leadership can gauge their level of readiness for a Sepsis Early Detection & Treatment Program (Appendix A).
- Plan: Hospital governance, senior administrative leadership, and clinical/safety leadership must close their own performance gap by implementing a comprehensive approach to addressing the performance gap (Strategy to Evaluation).
- Timeline set: A goal date should be set to implement the plan to address the gap with measurable quality indicators - “Some is not a number. Soon is not a time.
- Resources allocated: Specific budget allocations for the plan should be evaluated by governance boards and senior administrative leaders.
- Systems leadership and engagement: Clinical/safety leadership should endorse the plan and drive implementation across all providers and systems.
- Training and protocols: An effective sepsis program should include the training of prehospital personnel and the development of prehospital care protocols
Practice Plan
Fill in from google doc
Technology Plan
Suggested technologies are limited to those proven to show benefit or are the only known technologies with a particular capability. Other technology options may exist or emerge after the publication of this APSS, please send information on any additional technologies, along with appropriate evidence, to
info@patientsafetymovement.org.
- Electronic Health Record (EHR)
- Web-based/EHR predictive algorithms that elicit specific data such as but not limited to vital signs (BP, Temp, HR, RR, and SpO2) lab values, nurses notes, and event reports.
- EHR serves as a data collection tool and repository for predicting risk of sepsis for patients. A system that provides a data collection tool that allows for continuous analysis and surveillance could be most beneficial.
- System must be able to identify SIRS criteria and offer clinical decision support (CDS) to healthcare professionals (such as EPIC system developed collaboratively with UCSF or Cerner implementation at Intermountain Healthcare).
- Continuous pulse oximetry:
- Adhesive pulse oximetry sensor connected with pulse oximetry technology proven to accurately measure through motion and low perfusion to avoid false alarms and detect true physiologic events, with added importance in care areas without minimal direct surveillance of patients (Masimo SET® pulse oximetry, in a standalone bedside device or integrated in one of over 100 multi-parameter bedside monitors).\cite{20098128,22626683}
- Remote monitoring and notification system
- Remote monitoring with direct clinician alert capability compatible with pulse oximetry technology compatible with recommended pulse oximetry technology (Masimo Patient Safety Net™, or comparable multi-parameter monitoring system)
- Direct clinician alert through dedicated paging systems or hospital notification system.
- Medical-grade wireless network suitable to permit reliable, continuous remote monitoring and documentation during ambulation and/or transport.
- Alternatively, a wired network can be used which allows surveillance of patients while they are in bed but not while they are ambulating.
Patient Engagement
Current strategies to reduce loss of life from sepsis focus on data collection and analysis to establish life-saving protocols. This logical starting point must evolve quickly to seek innovative ways to engage patients and families as safety partners.
Health care advocates have long supported patient education and engagement as a means to reduce the incidence of all medical events, including sepsis. A significant struggle is the public’s lack of awareness of the existence and the prevalence of sepsis, which hinders their ability to recognize and report early signs of the disease.
The public desperately needs resources to provide information and support to help them assist in efforts to screen, prevent, recognize, diagnose and to pursue evidence-based intervention and treatment. Those afflicted and their loved ones need assistance in coping during the immediate recovery period and in knowing what to expect during the oftentimes protracted post-sepsis healing process.
A foundation of information is needed in conjunction with public awareness campaigns. Helping the public develop basic skills and confidence and providing them with appropriate support both during and after a sepsis diagnosis is the key to reducing the injuries and deaths from sepsis. To achieve these goals, public involvement in the initial strategic efforts must be an integral part of developing sepsis protocols.
Sepsis Resources for the Public:
Metrics
Topic
Sepsis Mortality Rate
Rate of mortality for severe sepsis and/or septic shock patients per 1,000 patients with severe sepsis and/or septic shock
Outcome Measure Formula
Numerator: Number of inpatient mortalities for patients with severe sepsis and/or septic shock
Denominator: Total number of patients with severe sepsis and/or septic shock diagnosis codes that are admitted to the intensive care unit from the emergency department or from an acute floor setting.
*Rate is typically displayed as Mortalities/1,000 Patients
Metric Recommendations
Direct Impact: All Patients with severe sepsis and/or septic shock
Lives Spared Harm:
\(Lives\ =\ \left(Mortality\ Rate_{baseline}\ -\ Mortality\ Rate_{measurement}\right)\ x\ Patients\ _{baseline}\)
*Patientsbaseline: the total number of patients that are counted with the diagnosis of severe sepsis and/or septic shock
Notes: Patients with severe sepsis and/or septic shock are determined by the following ICD9 diagnosis codes: 995.92 (Severe Sepsis) and 785.52 (Septic Shock). Additionally, patients must be admitted to the intensive care unit from the emergency department or from an acute floor setting. If feasible, manual review of diagnosis codes is desirable due to the complex nature of sepsis.
Data Collection: Data may be pulled from electronic billing data with the above diagnosis codes. Additionally, data may be collected exclusively through manual chart review, or a hybrid method of chart review and electronic billing data.