A health system task force developed this statement to support a system-wide definition of sepsis and assist with fighting denials from managed care insurers. According to the health system, “The Task Force strongly encourages the use of standardized criteria within and across the Health System. Additionally, the Task Force recognizes that definitions or guidelines will not always apply to every patient encounter and therefore, each physician/provider is expected to use appropriate professional judgment when applying these guidelines. Consensus Statement recommendations are likely to change with new information.”
CONSENSUS STATEMENT on Sepsis (SEPSIS-2) – Adults
Background
Currently, there is variability in diagnostic criteria for the definition of Sepsis (SEPSIS-2 vs. SEPSIS-3). Despite the call for early and accurate identification of sepsis to drive treatment modalities that prevent organ failure and death, the published revised definition of SEPSIS-3, instead, focuses on the specificity of risk of mortality and prolonged ICU stay. Additionally, at this time, the SEPSIS-3 definition has only been validated by retrospective data from two U.S. hospital systems (University of Chicago and University of Pittsburgh Medical Center). Therefore, the Health System defines Sepsis as the Systemic Inflammatory Response Syndrome (SIRS criteria) specifically due to infection, also known as SEPSIS-2. This definition has resulted in a declining mortality rate across the world in centers that use it and is aligned with the definition used by Centers for Medicare & Medicaid Services (CMS) and International Classification of Diseases 10th Revision (ICD-10) Clinical Modification (ICD-10-CM) nomenclature. Screening for sepsis with SEPSIS-2 is more likely to capture patients earlier, before organ failure takes place, prompting more rapid initiation of life-saving interventions. Early initiation of appropriate antibiotics, source control of the infection, and supportive treatments such as IV fluid resuscitation remains the foundation of sepsis care.
Purpose
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Defining baseline system-wide criteria for diagnosing Sepsis (SEPSIS-2) provides an evidence-based strategy for quickly identifying and treating patients presenting with sepsis or severe sepsis criteria.
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Treatment strategies are in compliance with CMS requirements and the Surviving Sepsis Campaign (SSC) 2012.
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Sepsis related organ dysfunction variables as defined by SEPSIS-2, correlate with sequential (sepsis-related) organ failure assessment (SOFA) scores in SEPSIS-3.
Procedure
Key stakeholders of the Clinical Documentation Integrity (CDI) Task Force, which includes members from Quality, Hospitalists, Chief Medical Officers, Intensive Care physicians, Emergency Department physicians, infection control and prevention, Infectious Disease physician, respiratory therapy, clinical documentation and coding experts, have standardized SEPSIS-2 as the clinical working definition of Sepsis going forward. SIRS criteria will serve as the “clinical screen” and laboratory findings from the Sepsis bundle will serve as the “lab screen” to identify patients with sepsis, severe sepsis, and septic shock. Providers are encouraged to initiate the Sepsis Power Plan as it contains all necessary components for screening and treatment of sepsis. The sepsis power plans are updated to remain in compliance with CMS standards and SSC guidelines.
Definitions – Criteria for SEPSIS-2 Definition
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Documentation of infection
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Suspected source of infection by the physician/ARNP/PA or RN
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SIRS criteria (minimum of two)
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Temperature: ≥ 101.0°F
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Temperature: < 96.8°F
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Heart rate: > 90
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Respiratory rate: > 20
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Vital sign abnormalities (heart rate or respiratory rate) must be sustained for > 15 min
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To exclude this, there must be physician documentation that this is related to something else. If it is documented in the record, it must be abstracted as such.
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White blood cell count (WBC): >12,000
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WBC: <4,000
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Bandemia: >10%
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Severe sepsis: Sepsis plus one or more organ dysfunction variable(s) which includes:
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Systolic blood pressure (SBP): <90
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Mean arterial pressure: <65
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SBP decrease: >40 from known baseline - must be documented that this drop in SBP is related to infection or sepsis to be abstracted as such
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Creatinine: >2.0 (Excluded for ESRD)
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Urine output: <0.5 ml/kg/hr for >2 hours
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Bilirubin: >2.0
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Platelets: <100,000
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INR: >1.5 or PTT>60 seconds (Excluded if pt on anticoagulant)
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Lactate: >2
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Acute respiratory failure requiring mechanical ventilation including BiPAP or vent
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Acute septic encephalopathy defined as Altered Mental Status (AMS) related to infection and Glasgow Coma Scale (GCS) < 15. This is not for use in patients with baseline dementia.
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Septic shock: Severe sepsis with:
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Persistent hypotension (SBP <90 mm Hg) after 30 mL/kg IV fluid bolus OR
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Lactate ≥4
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CMS Definitions of Sepsis
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Sepsis is defined by CMS as the presence (probable or documented) of infection together with systemic manifestations of infection.
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Severe sepsis is defined as sepsis plus sepsis-induced organ dysfunction or tissue hypoperfusion. According to CMS abstraction criteria, the presentation of Severe Sepsis is the time the three criteria (documentation of infection, 2 or more SIRS criteria due to infection, & sepsis-related organ dysfunction) are noted within a six-hour period or physician documentation of severe sepsis or septic shock
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N.B. Intravenous fluid resuscitation with 30 mL/kg bolus is indicated when:
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Initial Hypotension -2 separate readings of SBP< 65 or
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Initial Lactate ≥ 4 is present
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Septic Shock is defined as severe sepsis with persistent hypotension/ hypoperfusion despite adequate fluid resuscitation after fluid bolus or a lactate ≥ 4.
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(Refer to the three-hour bundle criteria and the six-hour bundle criteria
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Treatment – Sepsis Bundles
The Surviving Sepsis Campaign (SSC) originated in 2004 as a response to increasing sepsis mortality rates with a lack of standardized care. Sepsis is a leading cause of death globally and in U.S. acute care hospitals (Kempker et al., 2020 & Rhee et. al 2017). The mortality rates for severe sepsis range from 30% to 50%, with increased risk associated with advanced age (Micek et al., 2006). Timely fluid resuscitation and early, correct antimicrobial therapy administration are linked with a 15% decrease in 28-day mortality rates (Micek et al., 2006). Furthermore, increased compliance with sepsis performance bundles has been associated with a 25% relative risk reduction in mortality rate (Levy et al., 2015). Identification and early treatment through standard protocols have improved survival rates and decreased costs.
CMS Requirements of the SEP-1 Bundle Core Measure
Three-hour presentation of severe sepsis
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Initial lactate measure
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Blood cultures drawn prior to antibiotics administration
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Broad spectrum or other antibiotics administered
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IV Fluid Resuscitation with 30ml/kg crystalloid fluids [initial hypotension or lactate ≥ 4mmol/L]. Same as above. Initial hypotension does NOT constitute septic shock.
Six-hour presentation of severe sepsis
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Repeat lactate (if initial lactate is elevated, > 2mmol/L)
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Vasopressors (if persistent hypotension 1 hour after fluid administration
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Volume status/tissue perfusion assessment
Repeat volume status and tissue perfusion assessment consisting of either:
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A focused exam documented by physician/ARNP/PA including:
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Vital signs AND
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Cardiopulmonary exam AND
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Capillary refill evaluation AND
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Skin examination OR
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A note stating “focused exam completed” will suffice
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Any two:
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Central venous pressure measurement
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Central venous oxygen measurement
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Bedside cardiovascular ultrasound
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Passive leg raise or fluid challenge
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All required elements are included in the Sepsis Post-Fluid Resuscitation Power Note. Additional information tables are available on defining initial resuscitation, screening, diagnosis, antimicrobial therapy, fluid therapy, vasopressors, inotropic therapy, blood administration and mechanical ventilation (Dellinger et al., 2013).
Core Measures Sepsis Exclusions
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Comfort measure only (CMO)
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Referral to hospice (within three-hour bundle time)
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Administration contraindication to care (i.e. Refusal of antibiotics, fluid or blood draw by patient or Health Care Surrogate)
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Length of stay >120 days
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Patient transferred from acute care facility
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Patient with severe sepsis who expires within three hours of presentation
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Patient with septic shock who expires within six hours of presentation
Strength/Level of Evidence
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Routine screening of potentially infected, seriously ill patients for severe sepsis to allow earlier implementation of therapy (Surviving Sepsis Campaign (SSC) grade 1C)
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Protocolized, quantitative resuscitation of patients with sepsis-induced tissue hypoperfusion (defined as hypotension persisting after initial fluid challenge or blood lactate concentration ≥ 4 mmol/L). Goals during the first six hours of resuscitation:
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Central venous pressure 8–12mm Hg
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Mean arterial pressure (MAP) ≥ 65mm Hg.
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Urine output ≥ 0.5mL/Kg/Hr.
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Central venous (superior vena cava) or mixed venous oxygen saturation 70% or 65%, respectively (SSC grade 1C)
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Obtaining appropriate cultures before antimicrobial therapy is initiated if such cultures do not cause significant delay (>45 minutes) in the start of antimicrobial(s) administration (SSC grade 1C).
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Targeting resuscitation to normalize lactate in patients with elevated lactate levels as a marker of tissue hypoperfusion (SSC grade 2C)
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Administration of effective intravenous antimicrobials within the first hour of recognition of septic shock (SSC grade 1B) and severe sepsis without septic shock (SSC grade 1C) as the goal of therapy
Note: The GRADE system, used by the Surviving Sepsis Campaign (SSC), is based on sequential assessment of the quality of evidence, followed by assessment of the balance between the benefits, risks, burden and cost, leading to development and grading of a management recommendation.
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A recommendation of 1 is a strong recommendation, while a recommendation of 2 is considered weak.
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The Letter A indicates high quality methodology with randomized controlled trials (RCTs). The Letter B indicates moderate quality methodology with downgraded RCTs or upgraded observational studies. Lastly, letter C indicates low quality methodology with well-done observational studies or control RCTs.
Best Practice Documentation and Coding Concepts
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Underlying infection, including suspected or confirmed source should be clearly documented when determined
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Indicate source of localized infection leading to sepsis (i.e. Pneumonia, Cellulitis, etc.)
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Document causal organism specificity if determined (i.e. Staph., Strep., etc.)
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Aspiration Pneumonia and Viral organisms CAN lead to a sepsis diagnosis
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Negative or inconclusive blood cultures DO NOT preclude the diagnosis of sepsis
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Indicate if SIRS criteria present due to underlying condition other than sepsis (i.e. SIRS, noninfectious origin, in the setting of burn, injury, trauma, heatstroke, etc.)
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Associated organ dysfunction
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Link sepsis to organ dysfunction when appropriate; document “associated with”, “due to” or “related to”, establishing a cause and effect relationship (i.e. severe sepsis associated with AKI, encephalopathy, etc.). Avoid using the term “with”, which does not imply a direct cause and effect in coding language but rather indicates the addition of another condition
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Document appropriately if the organ dysfunction is NOT related to sepsis (i.e. AKI due to renal infarcts, not associated with sepsis diagnosis)
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Modifiers should be documented when present
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Due to device, implant, graft, line, etc.
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Present on Admission (POA) vs. Not Present on Admission (NPOA) status should be clearly documented, or designated as “unable to clinically determine (UTD)” when suitable
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Indicate evolving, “ruled in” status, as well as resolution, or “ruled out” status
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Sepsis diagnosis should be carried through daily progress notes and into the discharge summary when applicable. The terms “probable”, “possible”, “likely”, or “suspected will capture coding if carried through to the discharge summary
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Urosepsis and Sepsis Syndrome are terms that CAN NOT be coded and do not exist in coding language
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ICD-10 Guidelines for Coding and Reporting are also in alignment with the SEPSIS-2 definition.
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SIRS, non-infectious origin without Sepsis (R65.1) – i.e., may be due to trauma, burns, malignant neoplasm, pancreatitis, heatstroke, major surgery, etc…)
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Sepsis without related organ dysfunction (A41.9)
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Severe Sepsis or Sepsis with related organ dysfunction (A41.9 + R65.20)
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Septic Shock (A41.9 + R65.21)
When the documentation supports these diagnoses, coding to the appropriate principal and secondary diagnosis codes feeds the decision support capabilities for ongoing quality assurance and performance improvement.
Citations
1. Dellinger RP, Levy MM, Rhodes A, Annane D, Gerlach H, Opal SM, Sevransky JE, Sprung CL, Douglas IS, Jaeschke R, Osborn TM, Nunnally ME, Townsend SR, Reinhart K, Kleinpell RM, Angus DC, Deutschman CS, Machado FR, Rubenfeld GD, Webb SA, Beale RJ, Vincent JL, Moreno R; Surviving Sepsis Campaign Guidelines Committee including the Pediatric Subgroup.
Surviving sepsis campaign: international guidelines for management of severe sepsis and septic shock: 2012. Critical Care Medicine. 2013 Feb; 41(2):580-637. doi:
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10.1097/CCM.0b013e31827e83af. PubMed PMID: 23353941.
2. Dicker, R.A. (2013) Cost Effectiveness in the Intensive Care Unit [PowerPoint slides]. Retrieved from
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http://www.ucsfcme.com/2013/MAN13002/slides/31.%20Dicker%20Cost%20Effectiveness%20in%20the%20Intensive%20Care%20Unit%202013.pdf
3. Micek, S.T., Roubinian, N., Heuring, T., Bode, M., Williams, J., Harrison, C.,…Kollef, M. (2006). Before-after Study of a Standardized Hospital Order Set for the Management of Septic Shock. Critical Care Medicine, 34(11), 2707-2713.
4. NQF-Endorsed Voluntary Consensus Standards for Hospital Care [Version 5.0]. (2015) Retrieved from
a. http://www.nhfca.org/psf/resources/Updates1/SEP1%20Measure%20Information%20Form%20( MIF).pdf
5. Palleschi, M.T., Sirianni, S., O’Connor, N., Dunn, D., Hasenau, S. (2014). An Interprofessional Process to Improve Early Identification and Treatment for Sepsis. Journal of Healthcare Quality, 36(4), 23-31.
6. Suarez, D., Ferrer, R., Artigas, A., Azkarate, I., Garnacho-Montero, J., Goma, G., …Ruiz, J.C.
7. (2011). Cost-effectiveness of the Surviving Sepsis Campaign Protocol for Severe Sepsis: A Prospective Nation-wide Study in Spain. Intensive Care Medicine 37, 444-452
8. Singer M, Deutschman CS, Seymour CW, et al. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016;315(8):801-810.
9. Kaukonen K-M, Bailey M, Pilcher D, Cooper DJ, Bellomo R. Systemic inflammatory response syndrome criteria in defining severe sepsis. New England Journal of Medicine. 2015;372(17):1629-1638.
10. Levy MM, Rhodes A, Phillips GS, et al. Surviving Sepsis Campaign: association between performance metrics and outcomes in a 7.5-year study. Crit Care Med. 2015;43(1):3-12.
11. Rhodes A, Phillips G, Beale R, et al. The Surviving Sepsis Campaign bundles and outcome: results from the International Multicentre Prevalence Study on Sepsis (the IMPreSS study). Intensive Care Medicine 2015;41(9):1620-1628.
12. Rhee C, Jones TM, Hamad Y, et al. Prevalence, Underlying Causes, and Preventability of Sepsis-Associated Mortality in US Acute Care Hospitals. JAMA Network Open. 2019; 2(2):e18771.
13. doi:10.1001/jamanetworkopen.2018.7571
14. Simpson SQ. New Sepsis Criteria: A Change We Should Not Make. Chest 2016;149:1117-8.
15. Marshall JC. Sepsis-3: What is the Meaning of a Definition? Crit Care Med 2016; 44:1459-60
16. Kempker JA, Martin GS. A global accounting of sepsis. Lancet, The, 2020-01-18, Volume 395, Issue 10219, Pages 168-170