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. 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 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

Practice Plan

Surveillance:

Screening:

  • Start sepsis protocol and assess if patient has other organ dyfunctions (laboratory dependent)
  • Lactate >2 mmol/L
  • Decrease in urine output or acutely increased creatinine
  • Bilirubin >2 mg/dL
  • Platelet count <100,000/mL (or 100 K/µL) or coagulopathy
  • If organ dysfunction is present (i.e. severe sepsis) start sepsis bundle (or septic shock bundle) as per the treatment section below
  • If qSOFA is positive (two of the following: altered mental status, respiratory rate ≥ 22/min, systolic blood pressure ≤100 mmHg) then increase monitoring and assess for ICU admission

Communication:

Treatment/Intervention:

  • Measure central venous pressure (CVP)
  • Measure central venous oxygen saturation (ScvO2)
  • Bedside cardiovascular ultrasound
  • Dynamic assessment of fluid responsiveness (PVI) with passive leg raise or fluid challenge

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.

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.Direct observation of hand hygiene practices in identified clinical settings with one (or two) trained and validated observers. Observers will watch healthcare workers’ hand hygiene practices at the point-of-care. The observer openly conducts observations but the identities of the healthcare workers are confidential. Based on WHO Guidelines on Hand Hygiene in Healthcare (2009) and “Save lives, Clean Your Hands” campaign.(World Health Organization 2009)

Limitations: 

Sepsis mortality rates are derived by healthcare organizations differently. We recommend risk adjusting the outcome measure, in this case mortality, and consider exclusion criteria such as: DNR status, comfort care as goal of care established.

Settings: 

Intensive care units, emergency department, and acute floor settings.

Mortality (will be calculated by the Patient Safety Movement Foundation)

The PSMF, when available, will use the mortality rates associated with Hospital Acquired Conditions targeted in the Partnership for Patient’s grant funded Hospital Engagement Networks (HEN). The program targeted 10 hospital acquired conditions to reduce medical harm and costs of care. “At the outset of the PfP initiative, HHS agencies contributed their expertise to developing a measurement strategy by which to track national progress in patient safety—both in general and specifically related to the preventable HACs being addressed by the PfP. In conjunction with CMS’s overall leadership of the PfP, AHRQ has helped coordinate development and use of the national measurement strategy. The results using this national measurement strategy have been referred to as the “AHRQ National Scorecard,” which provides summary data on the national HAC rate.\cite{sepsis13}

Appendix A: Questionnaire

Sepsis Early Detection and Treatment Program Questionnaire

Organization query

1. Demographics: hospital bed count; type: community, academic; Electronic Health Record vendor
2. Are there dedicated resources for a Sepsis Program/Sepsis as quality measure?
a. Does your hospital have a defined sepsis program? Y/N
b. Is there dedicated staff to lead the sepsis program? Y/N
c. What department is the program housed within?  Quality, Nursing, Central hospital administration, others?
3. Is there ongoing formal sepsis education offered for:
a. Nurses
b. Physicians, NPs/PAs
c. Allied health team members (Pharmacists, Rehab Therapists, Respiratory Therapists, et al)

Sepsis Screening/Surveillance

1. Does your hospital have a standardized surveillance or routine screening process for early detection of sepsis, severe sepsis, and/or septic shock?  Y/N/NA   If yes, see below:
a. Locations that have standardized surveillance:  ED, Urgent care, Acute care, transitional care, ICU, other
b. Is there automated continuous surveillance of data in electronic health record? Y/N
i. Who receives alerts? –RN, MD, Pharmacy, Rapid response clinicians others, all
ii. What action does the alert prompt/activate? –Notification instructions, bringing clinicians to see patient, orders for care diagnostics or interventions  other
c. Is there intermittent routine screening by clinicians/nurses using a standardized process e.g. sepsis checklist, section of assessment flow-sheet, etc?
i. What is the frequency of intermittent screening? Every 8 hrs, 12 hrs, 24 hrs, and/or PRN change in patient condition
ii. What action does the intermittent screening result prompt/activate? Notification instructions, bringing clinicians to see patient, orders for care diagnostics or interventions, other
2. Does your Emergency Department have an active surveillance or routine screening process for early detection of sepsis, severe sepsis, septic shock? Y/N/NA
a. If yes, is it electronic-based? Y/N
3. Does your Urgent Care Department have an active surveillance or routine screening process for early detection of sepsis, severe sepsis, septic shock?  Y/N/NA
a. If yes, is it electronic-based? Y/N

Sepsis management

1. Does your hospital have a standardized sepsis care bundle as part of a protocol, policy, order set? Y/N/NA
a. If yes, see below:
i. Which of the following are included in your sepsis care bundle?
1. Obtain lactate level
2. Obtain blood cultures/other cultures (urine, CSF, wound, etc) before antimicrobial agent administration
3. Administer broad-spectrum antimicrobial agents within 1 hour of time of presentation (for inpatients) or within 3 hours of time of presentation (for ED patients)
4. Administer IV fluid challenge for hypotension or lactate ≥ 4 mmol/L
5. Administer vasopressor medications to maintain MAP ≥ 65 mmHg after IV fluid challenge and within 6 hours of time of presentation
6. Obtain a follow up lactate level if initial lactate was elevated (>2), to evaluate    resuscitation interventions (Target is normalization of lactate level)
7. If persistent hypotension, after 1-hour from completion of the 30 mL/kg IV fluid challenge resuscitation or lactate ≥ 4 mmol/L, measure CVP and/or Scv02 levels (Target is CVP 8-12 mmHg, Scv02 of ≥70% -these targets are being debated based on recent trial  results –ARISE, PROCESS, PROMISE)

Measurement – What are the metrics used? What are the measurement procedures (manual, automated reports, etc)?  Where is measurement data reported to?

1. Screening compliance, screening tool accuracy (sensitivity/specificity)
2.Sepsis care/management bundle compliance
a. CMS National Hospital Inpatient Quality Measure
b. Reporting based on hospital discharges October 2015
3. Outcomes
a. Sepsis-associated mortality (hospital)
Patient/Family Engagement
1. Are materials or resources (website, classes, pamphlets, videos, etc) available for patients and families regarding:
a. Sepsis –what it is, risks, prevention, early detection, management, possible trajectory (ICU, post-ICU), outcomes –post-hospital resources
i. How you, as the patient or family member, can participate in prevention and early detection
b. The hospital’s sepsis program –what, when, who, etc?  e.g. screening, code sepsis, etc
c. For hospitals without a sepsis program – Do you have a rapid response team or a Condition H program?
d. Is your rapid response or Condition H also patient-activated?
e. How are patients and families alerted and oriented to the rapid response system?
f. Which provider or department is the contact point if the patient or family suspects infection or sepsis after discharge?