- ngagement: 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
Surveillance:
- Implement an effective monitoring system to accomplish continuous monitoring and notification based upon changes in the following data:
- Fever (> 38.3°C);
- Hypothermia (temperature < 36°C);
- Heart rate > 90/min or 1 or more than two standard deviations above the normal value for age;
- Tachypnea (RR > 20)
- Altered mental status;
- Hyperglycemia (plasma glucose > 140 mg/dL or 7.7 mmol/L) in the absence of diabetes;
- Leukocytosis (WBC count > 12,000 μL–1);
- Leukopenia (WBC count < 4000 μL–1);
- Normal WBC count with greater than 10% immature forms;
- Plasma C-reactive protein more than two standard deviations above the normal value;
- Plasma procalcitonin more than two standard deviations above the normal value;
- Hypotension (SBP < 90 mm Hg, MAP < 70 mmHg, or an SBP decrease > 40 mmHg in adults or less than two standard deviations below normal for age);
- Hypoxemia (Pao2 < 60 mmHg or Sp02 < 90%)
- Acute oliguria (urine output < 0.5 mL/kg/hr. for at least 2 hrs. despite adequate fluid resuscitation);
- Creatinine increase > 0.5 mg/dL. or 44.2 μmol/L;
- Coagulation abnormalities (INR > 1.5 or aPTT > 60 sec);
- Thrombocytopenia (platelet count < 100,000 μL–1);
- Hyperbilirubinemia (plasma total bilirubin > 4 mg/dL or 70 μmol/L);
- Hyperlactatemia (> 2 mmol/L);
- Prolonged capillary refill time or mottling.
- EtCO2 (< 25mmHg)
- Distribute the above "sepsis detection checklist" to all hospital care areas.
Screening:
- Formally assess opportunities to identify sepsis and to improve outcomes for those patients that acquire and are at risk for sepsis. Implement strategies that will identify an early sepsis warning.
- Implement systematic protocols for early identification and time-sensitive evidence-based treatment of sepsis.
- Formalize a process to screen patients for signs of sepsis throughout the entire institution
- Implement a sepsis response team or incorporate early detection of sepsis into existing medical emergency teams (e.g. rapid response teams)
- Identify the opportunities for implementation of a sepsis response team and protocol for initiating a sepsis response call for patients who have been identified as potentially septic
- Screening workflow specific to the type and level of alert
- Two SIRS criteria met: temperature >38.3ºC or <36ºC, heart rate >90 beats/min, respiratory rate >20 breaths/min, white blood cell count >12,000 µL (or 12K/µL) or 4,000 µL (or 4K/µL) OR
- Clinically assessable organ dysfunction: altered mental status, respiratory failure (dyspnea, elevated respiratory rate, desaturation), hypotension (systolic blood pressure <90 mmHg or decrease >40 mmHg from baseline, mean arterial pressure <70 mmHg)
- Assess for infection, if patient has a serious infection
- 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:
- Implement standardized protocols for patient/family engagement/communication
- Implement standardized protocols for patient/family engagement/communication
- Coordinate with family or caregiver to reduce sepsis risk factors and identify clinical indicators at first sign;
- Disclose all sepsis related events;
- Provide an explanation as to why/how the sepsis occurred;
- Explain how the effects of sepsis will be minimized; and
- Discuss/state steps that the caregiver or organization will take to prevent recurrences of sepsis.
Treatment/Intervention:
- Adhere to the Surviving Sepsis Campaign practices as noted by the Society of Critical Care Medicine.9
- Formalize workflows for clinicians to adhere to after a patient sepsis alert has been noted.
- For sepsis implement workflow for rapid assessment and intervention at the bedside and initiate sepsis bundle (3 hour elements)
- Measure lactate level and base deficit
- Obtain blood cultures prior to administration of antibiotics
- Administer broad spectrum antibiotics
- Administer 30 mL/kg Crystalloid for hypotension or lactate ≥4 mmol/L
- Remeasure lactate if initial lactate was elevated
- For septic shock implement workflow for rapid assessment, intervention and need for higher level of care and initiate septic shock bundle (6 hour elements)
- Apply vasopressors (for hypotension that does not respond to initial fluid resuscitation to maintain a mean arterial pressure (MAP) ≥65 mm Hg)
- In the event of persistent hypotension after fluid administration (MAP <65 mmHg) or if the initial lactate was ≥ 4 mmol/L (36 mg/dL), reassess volume status and tissue perfusion by:
- Either repeat focused exam by licensed independent practitioner including vital signs, cardiopulmonary, capillary refill, pulse and skin findings.
- OR two of the following:
- 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
- Remeasure lactate if initial lactate was elevated
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.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?