Special Panel Session: New Sepsis Definition

Special Panel Session: New Sepsis Definition 1

Today s Panelists Include: Richard Pinson, MD, FACP, CCS, Principal and Medical Director, Pinson and Tang Consultants James S. Kennedy, MD, CCS, CCDS, CDIP, President, CDIMD Sam Antonios, MD, FACP, FHM, CCDS, Medical Director of Information Systems and CDI, Via Christi, Kansas Moderated by James Fee, MD, CCS, CCDS, VP, Enjoin Sepsis 3 Orientation: What s a CDI to Do? 2

Learning Objectives At the completion of this educational activity, the learner will be able to: Discuss the evolution of the term sepsis in the following environments: Clinical Administrative The International Classification of Disease Other (such as clinical abstraction for databases) Define how to use the word sepsis and its derivatives (e.g., severe sepsis) in these three environments 3

1991 Definition of SIRS/Sepsis Sepsis 1 Systemic inflammatory response syndrome (SIRS) 1. Body temperature > 38 Cor< 36 C 2. Heart rate > 90/minute 3. Respiratory rate > 20/minute or PaCO 2 < 32 mmhg 4. White blood cell count > 12,000/μL or < 4,000/μL Sepsis SIRS due to infection Severe sepsis sepsis with acute organ dysfunction 2 out of 4 Chest. 1992 Jun;101(6):1644 55 4

Sepsis 2 (2001 to February 22, 2016) Infection, Documented or Suspected and Some of the Following: General variables Fever (> 38.3 C) Hypothermia (core temperature < 36 C) Heart rate > 90/min or more than two SD above the normal value for age Tachypnea Altered mental status Significant edema or positive fluid balance (> 20 ml/kg over 24 hr) Hyperglycemia (plasma glucose > 140 mg/dl or 7.7 mmol/l) in the absence of diabetes Inflammatory variables Leukocytosis (WBC count > 12,000/μL) Leukopenia (WBC count < 4000/μL) Normal WBC count with greater than 10% immature forms Plasma C reactive protein more than two SD above the normal value Plasma procalcitonin more than two SD above the normal value Hemodynamic variables Arterial hypotension (SBP < 90 mmhg, MAP < 70 mmhg, or an SBP decrease > 40 mmhg in adults or less than two SD below normal for age) Organ dysfunction variables Arterial hypoxemia (Pao2/Fio2 < 300) 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 s) Ileus (absent bowel sounds) Thrombocytopenia (platelet count < 100,000 μl 1) Hyperbilirubinemia (plasma total bilirubin > 4 mg/dl or 70 μmol/l) Tissue perfusion variables Hyperlactatemia (> 1 mmol/l) Decreased capillary refill or mottling Source: http://www.sccm.org/documents/ssc-guidelines.pdf 5

Sepsis 2 Severe Sepsis Induced Organ Dysfunction/Hypoperfusion The physician must state that the organ dysfunction is due to sepsis to qualify as severe sepsis Source: http://www.sccm.org/documents/ssc-guidelines.pdf 6

Sepsis Adult Redefinition (Sepsis 3) February 22, 2016 Announced at the SCCM meeting in Orlando on February 22, 2016 Published in JAMA on February 23, 2016 http://jamasepsis.com 7

Sepsis 3 Adult Redefinition Requirement for Organ Dysfunction Sepsis is now defined as a life threatening organ dysfunction due to a dysregulated host response to infection In this new definition, the concept of the non homeostatic host response to infection is strongly stressed while the SIRS criteria have been removed The inflammatory response accompanying infection (pyrexia, neutrophilia, etc.) often represents an appropriate host response to any infection, and this may not necessarily be life threatening 8

Sepsis 3 Adult Redefinition Organ Dysfunction SOFA Scores The key element of sepsis induced organ dysfunction is defined by an acute change in total SOFA score 2 points consequent to infection, reflecting an overall mortality rate of approximately 10% The baseline Sepsis related Organ Failure Assessment (SOFA) score may be taken as zero unless the patient is known to have previous comorbidity (e.g., head injury, chronic kidney disease, etc.) In light of this, the current definition of severe sepsis becomes obsolete, as does the term 9

Sepsis 3 Adult Redefinition SOFA Scores PaO 2 /FiO 2 (mmhg) SOFA score Bilirubin (mg/dl) [μmol/l] SOFA score < 400 1 1.2 1.9 [> 20 32] 1 < 300 2 2.0 5.9 [33 101] 2 < 200 and mechanically ventilated 3 6.0 11.9 [102 204] 3 < 100 and mechanically ventilated 4 > 12.0 [> 204] 4 Glasgow Coma Scale SOFA score Platelets 10 3 /µl SOFA score 13 14 1 < 150 1 10 12 2 < 100 2 6 9 3 < 50 3 < 6 4 < 20 4 Mean Arterial Pressure OR administration of vasopressors required SOFA score Creatinine (mg/dl) [μmol/l] (or urine output) SOFA score MAP < 70 mm/hg 1 1.2 1.9 [110 170] 1 dop <= 5 or dob (any dose) 2 2.0 3.4 [171 299] 2 dop > 5 OR epi <= 0.1 OR nor <= 0.1 3 3.5 4.9 [300 440] (or < 500 ml/d) 3 dop > 15 OR epi > 0.1 OR nor > 0.1 4 > 5.0 [> 440] (or < 200 ml/d) 4 Still need diagnoses to support these clinical indicators 10

2016 Adult Definition of Sepsis Sepsis 3 Clinical SEPSIS PANCREATITIS Organ dysf INFECTION SEPTIC SHOCK Organ dysf SIRS Organ dysf BURNS OTHER Organ dysf Organ dysf TRAUMA 11

Discussion/Questions In order to receive your continuing education certificate(s) for this program, you must complete the online evaluation. The link can be found in the continuing education section at the front of the program guide. 12

New Definitions of Sepsis and Septic Shock: Response from the ACDIS Advisory Board POSITION PAPER Summary On February 23, 2016, the Journal of the American Medical Association (JAMA) published definition updates for sepsis and septic shock.1 The following is a response from members of the ACDIS Advisory Board. Its purpose is to summarize the importance of these published articles, render analysis and preliminary opinion on their documentation and coding implications, and offer advice on how CDI departments may wish to respond within their facilities. The task force published that sepsis should be defined as a life-threatening organ dysfunction caused by a dysregulated host response to infection. Background Systemic inflammatory response syndrome (SIRS), sepsis, severe sepsis, and septic shock were initially defined in 1991 by a consensus panel convened by the AmericanCollege of Chest Physicians (ACCP) and the Society of Critical Care Medicine (SCCM).2 The definitions were revisited in 2001 during the International Sepsis Definitions Conference, which included members from the ACCP, the SCCM, the American Thoracic Society (ATS), the European Society of Intensive Care Medicine (ESICM), and the Surgical Infection Society (SIS).3 The February 23, 2016, issue of JAMA included three articles from the Sepsis Definitions Task Force to update the definition of sepsis and offer the validation studies done to support the updates. In their definition article, Singer and colleagues described the relevance, process followed, and findings from the available evidence to develop the third iteration of consensus conference definitions for sepsis and septic shock.1 A major support for the new change was the use of analyses in large cohorts of patients from electronic health records (EHR) and database from the Surviving Sepsis campaign to provide quantitative evidence.4,5 The updated definitions publications (Sepsis-3) A 19-member joint task force of the SCCM and the ESICM developed the guidelines through expert consensus and literature review, as well as by studying data from EHR-recorded encounters of patients with suspected infections. The task force published that sepsis should be defined as a life-threatening organ dysfunction caused by a dysregulated host response to infection. Septic shock was defined in Singer et al. s article as [s]epsis with circulatory and cellular/metabolic abnormalities profound enough to substantially increase mortality. Thirty-one medical societies listed in the acknowledgment section of the article endorsed the proposed definition.1 The task force analyzed the SIRS criteria, Sequential (Sepsis-related) Organ Failure Assessment (SOFA) score, and Logistic Organ Dysfunction System (LODS) for validity in predicting mortality for patients with suspected hospital- or community-acquired infections. Of note, the SOFA score has been used clinically in critical care settings

New Definitions of Sepsis and Septic Shock: Response from the ACDIS Advisory Board and in research to evaluate organ dysfunction among patients in the intensive care unit (ICU) based on clinical and laboratory measurements of several physiological parameters.6 LODS is another type of clinical scoring tool used to determine severity levels and projection of a probability of mortality.7 The task force s analysis showed that among adult patients with suspected infections in the ICU, the predictive validity of SOFA and LODS for patient mortality were statistically similar to each other, and both were higher than the validity of the SIRS criteria. According to the article, a patient with a diagnosed or suspected infection with an increase of two points or more from the baseline SOFA score meets the criteria for sepsis. As a result of the proposed definition update, the task force considered the terminology severe sepsis to be superfluous. The authors wanted to move away from the concept of spectrum of disease. Because SOFA requires laboratory tests, the task force also recommended that clinicians use another scoring tool called quick SOFA (qsofa) to evaluate patients for possible sepsis outside of the ICU but only as a screening tool. The task force reported that the qsofa score, which includes altered mental state, systolic blood pressure of 100 mm Hg or less, and respiration rate of 22 breaths/minute or greater, is a trigger that the patient be more closely monitored, given more intensive treatment, and possibly referred to critical care. Based on results from a systematic literature review and meta-analysis of observational studies, and the Surviving Sepsis campaign s registry of 28,150 patients, the article also updated the definition of septic shock to sepsis with underlying circulatory and cellular/metabolic abnormalities that can result in substantially greater mortality. The clinical identification criteria are: sepsis with hypotension needing vasopressor therapy to maintain a mean arterial pressure of 65 mm Hg or greater, and serum lactate level greater than 2 mmol/l (>18 mg/dl) despite adequate volume resuscitation. As a result of the proposed definition update, the task force considered the terminology severe sepsis to be superfluous. The authors wanted to move away from the concept of spectrum of disease. The task force recognized the following facts in its publication: Sepsis is not a specific illness but rather a syndrome encompassing a stilluncertain pathobiology. Sepsis is a syndrome without a validated criterion standard diagnostic test. Nonspecific SIRS criteria will continue to aid in the general diagnosis of infection. The SIRS criteria do not necessarily indicate a dysregulated, life-threatening response. SIRS criteria are present in many hospitalized patients, including those who never develop infection and never incur adverse outcomes. No current clinical measures reflect the concept of a dysregulated host response. APRIL 2015 2 2016 by HCPro a division of BLR, Any reproduction is strictly prohibited. For more information, call 877 233 8734 or visit www.cdiassociation.com.

New Definitions of Sepsis and Septic Shock: Response from the ACDIS Advisory Board ACDIS Advisory Board preliminary opinion The ACDIS Advisory Board met on February 26, 2016, following the release of the JAMA publications, to discuss the impact of the proposed definition updates on clinical documentation specialists and their day-to-day efforts, as well as the implications for documentation, coding, and CMS quality measures. The board reviewed the published articles and has also consulted with documentation and coding experts. Below are a few notes from the review process. This process is still in its preliminary stage and will continue as Advisory Board members gather facts, listen to members, and engage other clinical leaders, regulatory leaders, and stakeholders involved with coding and ICD-10. The publications gave explicit coding recommendations, listing two specific ICD- 10 codes to be used. The ACDIS Advisory Board is concerned about these recommendations 1. The work presented by the Sepsis-3 task force ( Assessment of Clinical Criteria for Sepsis, Assessment of Clinical Criteria for Septic Shock, and Consensus Definitions for Sepsis and Septic Shock ) was well researched and employed scientific rigor to study clinical criteria beyond the expert opinion of the task force itself. This raises the level of confidence in the evidence that was presented. 2. The data was based on large databases of patients, allowing analysis based on clinical findings and not administrative claims; this further strengthens the findings. 3. The updated definitions were endorsed by 31 scientific societies. Some of these societies are U.S. based, while others are non-u.s. based or international. 4. The updated definitions are for adults only and exclude pediatric populations. 5. The SOFA score is not intended to be used as a tool for patient management, but as a means to clinically characterize a septic patient. 6. Depending on a patient s baseline level of risk, a SOFA score of 2 or greater identified a two- to 25-fold increased risk of mortality compared with patients with a SOFA score less than 2, when the baseline is 0. The application of SOFA must be from the patient s baseline when there are other comorbidities. 7. There is a distinction drawn between the new definition of sepsis (or septic shock) and clinical criteria used to identify sepsis (or septic shock), based on the absence of a gold-standard diagnostic test and the importance of recognition from a clinical perspective. The Advisory Board also identified several significant concerns regarding the publications: 1. The publications gave explicit coding recommendations, listing two specific ICD-10 codes to be used. The ACDIS Advisory Board is concerned about these recommendations. For hospitals in the United States, coding of diseases must follow the ICD-10-CM Official Guidelines for Coding and Reporting, as published by the Cooperating Parties (the American Health Information Management Association, the American Hospital Association, the Centers for Medicare and Medicaid Services [CMS], and the National Center for Health APRIL 2015 2 2016 by HCPro a division of BLR, Any reproduction is strictly prohibited. For more information, call 877 233 8734 or visit www.cdiassociation.com.

New Definitions of Sepsis and Septic Shock: Response from the ACDIS Advisory Board Statistics). Coding of specific conditions is dependent on documentation within the medical record and follows rules established to determine selection and sequencing, amongst other coding conventions. 2. The authors acknowledge that neither qsofa nor SOFA are intended to be a stand-alone definition of sepsis. This leads us to believe that the clinical judgment of a physician examining these clinical findings, in combination with potential other factors, should be the ultimate basis for diagnosis of sepsis and septic shock. The 2001 definition consensus emphasized the role of the clinician at the bedside, but this was not elaborated on in the updated definitions. 3. It is not entirely clear why only the stated outcomes (hospital mortality, ICU stay of three days or longer, or both) were used to assess predictive validity both overall and across deciles of baseline risk. Although the ability to predict mortality and ICU stays is important from a clinical perspective, it may not always fit the need to define a disease or syndrome. Other morbidity outcomes were not used. 4. The articles emphasize that early recognition is particularly important because prompt management of septic patients may improve outcomes. This has been proven in the literature. However, the recommended scoring tool (SOFA) is complex and potentially not accessible. This is particularly true for PaO2, which would require an arterial blood gas measurement. The board also noted the uncertainty of how to deal with baseline mental status changes and/or baseline abnormal SOFA. Although the qsofa is intended to provide simple bedside criteria to identify adult patients with suspected infection, it would only serve as a screening tool to prompt clinicians to further investigate for organ dysfunction, to initiate or escalate therapy as appropriate, and to consider referral to critical care or increase the frequency of monitoring. 5. While the guidelines rely more on concrete physiological criteria for diagnosing sepsis, it remains uncertain whether there will be gains in clinical precision or standardization. 6. The updated definitions create a direct conflict with the current CMS clinical quality measure for process, SEP-1, which is part of the Inpatient Quality Reporting Program (IQR). Hospitals participating in IQR are required to submit abstracted data according to the specifications manual of each quality measure. The SEP-1 specification manual has not yet included any updates in relation to the updated definitions (Sepsis-3) as of February 26, 2016. The manual instructs abstractors to follow a specific path to collect data about compliance with the three-hour and six-hour bundle. For example, recent release notes for version 5.0b of SEP-1 state: Documentation of sepsis is not an acceptable alternative for documentation of severe sepsis. The authors of APRIL 2015 2 2016 by HCPro a division of BLR, Any reproduction is strictly prohibited. For more information, call 877 233 8734 or visit www.cdiassociation.com.

New Definitions of Sepsis and Septic Shock: Response from the ACDIS Advisory Board the JAMA articles did not comment on the quality measure; this may be due to the fact that it is a CMS measure limited to the United States. 7. It was not clear from the publications if the authors intend on submitting requests for changes in ICD-10 coding guidelines for sepsis and septic shock at the upcoming ICD-10 coordination and maintenance committee meeting. This would obviously be in relation to U.S.-based coding. Conclusion We recognize that most clinical documentation specialists have felt the rug being pulled from underneath them with the newly published definition updates for sepsis and septic shock. They represent a significant change from the 2001 definitions. The publications set forth compelling evidence that cannot be dismissed; however, it remains to be seen how the clinical community will be able to operationalize or change its understanding of sepsis and septic shock. This situation is somewhat analogous to what happened when the SCIP measure for beta blockers was at odds with Society of Thoracic Surgeons recommendations. As was the cast then, it takes time for evidence to be promulgated and incorporated into clinical practice or quality measures. In the meantime, the ACDIS Advisory Board recommends the following: Obtain a full understanding of the updated definitions. CDI specialists should read the three published JAMA articles listed in the reference section below. It is also recommended that physician advisors who work with clinical documentation specialist read the articles in depth. Go directly to the source articles, not to second-hand analysis. Avoid using interpretations of the definitions that may be published in a variety of other sources. Because the updated definitions are complex, there is a high likelihood that lay media will misrepresent them. In the short period of time since their publication, the Advisory Board has already noticed erroneous information being disseminated. Work closely with your physician advisors, the members of the medical staff, and your quality department to decide how to clinically validate sepsis and provide supporting documentation while acknowledging the possible shift that may occur within the physician community. Each hospital or health system should establish its own standard at this point in time, while keeping in mind that further information might emerge. Avoid blindly following the coding recommendations in the articles. Discuss them with leadership first. Stay tuned for additional guidance from ACDIS. The ACDIS Advisory Board is already reaching out to other stakeholders in the realms of clinical practice, coding, and documentation to obtain further clarification about the implications of these new definitions for physician documentation. APRIL 2015 2 2016 by HCPro a division of BLR, Any reproduction is strictly prohibited. For more information, call 877 233 8734 or visit www.cdiassociation.com.

New Definitions of Sepsis and Septic Shock: Response from the ACDIS Advisory Board References 1. Singer, M., Deutschman, C. S., Seymour, C. W., Shankar-Hari, M., Annane, D., Bauer, M., Angus, D. C. (2016). The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA, 315(8), 757 759. Retrieved from http:// jama.jamanetwork.com/article.aspx?articleid=2492881 2. American College of Chest Physicians/Society of Critical Care Medicine Consensus Conference: Definitions for sepsis and organ failure and guidelines for the use of innovative therapies in sepsis. (1992). Crit Care Med, 20(6), 864. 3. Levy, M. M., Fink, M. P., Marshall, J. C., Abraham, E., Angus, D., Cook, D. SCCM/ESICM/ACCP/ATS/SIS. (2003). 2001 SCCM/ESICM/ACCP/ATS/SIS International Sepsis Definitions Conference. Crit Care Med, 31(4), 1250. 4. +Seymour, C. W., Liu, V. X., Iwashyna, T. J., Brunkhorst, F. M., Rea, T. D., Scherag, A., Angus, D. C. (2016). Assessment of clinical criteria for sepsis: For the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA, 315(8), 762 774. 5. Shankar-Hari, M., Phillips, G. S., Levy, M. L., Seymour, C. W., Liu, V. X., Deutschman, C. S., Singer, M. (2016). Developing a new definition and assessing new clinical criteria for septic shock: For the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA, 315(8), 775 787. 6. Ferreira, F. L., Bota, D. P., Bross, A., Mélot, C., & Vincent, J. (2001). Serial evaluation of the SOFA score to predict outcome in critically ill patients. JAMA, 286(14), 1754 1758. 7. Le Gall, J. R., Klar, J., Lemeshow, S., Saulnier, F., Alberti, C., Artigas, A., & Teres, D. (1996). The Logistic Organ Dysfunction system. A new way to assess organ dysfunction in the intensive care unit. ICU Scoring Group. JAMA, 276(10), 802 810. What is an ACDIS Position Paper? An ACDIS Position Paper sets a recommended standard for the CDI industry to follow. It advocates on behalf of a certain position or offers concrete solutions for a particular problem. All current members of the ACDIS advisory Board must review/approve a Position Paper and are encouraged to materially contribute to its creation. APRIL 2015 2 2016 by HCPro a division of BLR, Any reproduction is strictly prohibited. For more information, call 877 233 8734 or visit www.cdiassociation.com.

Sepsis 3.0: Progress or Peril By Richard D. Pinson, MD, FACP, CCS The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3)¹ published on February 23 in the Journal of the American Medical Association represents a radical departure from the prior sepsis definitions in 1991² (identified as Sepsis-1) and 2001³ (identified as Sepsis-2) and subsequent Surviving Sepsis Campaign (SSC) guidelines through 2015⁴ ⁵. Noting inadequate specificity and sensitivity of the systemic inflammatory response syndrome (SIRS) criteria, the new definitions discard the concept of sepsis as SIRS due to infection which has been the diagnostic standard for the last 25 years. The Sepsis-3 consensus concludes that the new definitions should replace previous definitions (without specifically stating that they do replace them) and that the process remains a work in progress. How will other professional societies, the medical community in general, payers and regulatory agencies respond to this radical change? Is it definitive or subject to comment and change? Could or should clinicians using their clinical judgement and the CDI team have the discretion to continue using Sepsis-2 criteria while awaiting the healthcare community s reaction to this new definition? All of this will play out in the real world setting of everyday medical practice, and only time will tell. The New Sepsis Criteria: Sepsis-3 defines sepsis as life-threatening organ dysfunction caused by a dysregulated host response to infection [suspected or confirmed]. Sequential [Sepsis-related] Organ Failure Assessment Score (SOFA) is used to define organ dysfunction as an increase in the total SOFA score of 2 points or more. The SOFA requirement is met by a minimum of 1 point increase in at least 2 organ systems or by a 2 point increase (or more) in a single organ system. With SOFA, the function of six organ systems is graded on a scale of 0 to 4 depending on the degree of dysfunction using objective measurements. Zero represents normal function. For each organ system, the baseline SOFA score is assumed to be 0 in patients who don t have preexisting organ dysfunction. Table 1: Sequential [Sepsis-Related] Organ Failure Assessment Points Organ system Objective Points measurement 0 1 2 3 4 Respiration PaO2/FIO2 1 > 400 < 400 < 300 < 200 with resp support < 100 with resp support Coagulation Platelet count > < 150,000 < 100,000 < 50,000 < 20,000 150,000 Liver Bilirubin (mg/dl) < 1.2 1.2-1.9 2.0-5.9 6.0-11.9 >12.0 Cardiovascular 2 MAP (mmhg) or MAP > MAP < 70 DPA < 5 DPA 5.1-15 DPA >15 vasopressor 70 CNS Glasgow Coma Scale Score 15 13-14 10-12 6-9 3-6

Renal Creatinine (mg/dl) < 1.2 1.2 1.9 2.0-3.4 3.5-4.9 >5.0 or urine output - - - <500 ml/d <200 ml/d 1 PaO2 = arterial partial pressure of oxygen (mmhg); FIO2 = fraction of inspired oxygen expressed as a decimal. 2 MAP = mean arterial pressure; DPA = dopamine in mcg/kg/min for > 1 hour; includes vasopressors other than dopamine. Derived by author from Singer et al.¹ Example: A 76 year old woman who has no prior history of kidney disease, dementia or other mental impairment is admitted for UTI, AKI with creatinine of 1.4 and altered mental status. A Glasgow Coma Scale score is done totaling 13. It is presumed that her renal and CNS baseline states are normal (SOFA scores = 0). She therefore has sepsis due to UTI since she now has a SOFA score of 1 in the renal and CNS categories for a total SOFA score of 2 points. Quick SOFA (qsofa) is a bedside clinical approach used to identify patients who are likely to have a prolonged ICU stay or die in the hospital, but it does not substitute for SOFA for defining organ dysfunction but indicates SOFA score should be calculated for >2 point change from baseline. Quick SOFA (qsofa) Criteria 2 or more: Altered mentation Respiratory rate >22 Systolic blood pressure < 100 mmhg Septic Shock The new definition of septic shock is quite strict: persisting hypotension requiring vasopressors to maintain MAP [mean arterial pressure] > 65 mmhg and having a serum lactate level >2 mmol/l despite adequate volume resuscitation. The requirement for both vasopressor-sustained MAP and an elevated lactate level seems extreme and inconsistent with other concepts and definitions of shock states. Coding and Documentation Implications Sepsis-3 states that the term severe sepsis was redundant indicating that sepsis without organ dysfunction does not exist. It appears that all cases of sepsis could now be considered severe sepsis having organ dysfunction; there would no longer be any cases of sepsis without organ dysfunction.

Unfortunately the Sepsis-3 definitions are inconsistent with the ICD-10-CM Official Guidelines for Coding and Reporting (OCG) which do distinguish between sepsis without organ dysfunction and sepsis with organ dysfunction. Sepsis-3 also makes erroneous recommendations for the primary codes to be used pursuant to the new definitions in the United States, identifying code R65.20 for sepsis and R65.21 for septic shock. Here we use ICD-10-CM, a modified version of the international ICD-10, and these codes are not primary sepsis codes at all. ICD-10-CM and the OCG require a primary code for sepsis (e.g., A41.9, unspecified organism or B37.7, candida sepsis) be sequenced first followed by code R65.20 for severe sepsis (sepsis with organ dysfunction) without septic shock if present, or R65.21 when septic shock is identified. The OCG and the ICD-10-CM classification itself do not require organ dysfunction be specified as due to sepsis (or severe sepsis stated) for assignment of R65.20 (Severe Sepsis), but having this documentation makes the connection indisputable. Based on Sepsis-3, it appears that acute organ dysfunction is intrinsically associated with sepsis because organ dysfunction is a necessary prerequisite for the diagnosis of sepsis. According to Sepsis-3, sepsis cannot be a valid diagnosis without organ dysfunction caused by an infection. If organ failure (dysfunction) as defined by SOFA is documented in the record as well as sepsis, it therefore must be associated with sepsis. How does this new sepsis definition impact the Surviving Sepsis Campaign (SSC) guidelines and quality reporting of sepsis? The 2012 SSC guidelines reaffirm and utilize the 2001 Sepsis-2 definitions. On March 1 st, SSC released its response to Sepsis-3⁶ stating that screening for early identification and treatment of patients with sepsis (formerly called severe sepsis) should continue essentially as has been previously recommended by SSC. Commenting on severe sepsis it says: sepsis (formerly called severe sepsis) should still be identified by the same organ dysfunction criteria, but adds that SOFA criteria and the qsofa screen can also be used to identify patients with severe sepsis for initiation of treatment. The CMS Hospital Inpatient Quality Reporting (Hospital IQR) program gives hospitals a financial incentive to report the quality of their services. Hospitals that do not successfully report IQR measures are financially penalized. One of these is a sepsis measure that utilizes the National Quality Forum (NQF) Severe Sepsis and Septic Shock management bundle (NQF #0500). It defines sepsis as 2 or more of 4 SIRS criteria (temperature, heart rate, respiratory rate and WBC) from the Sepsis-2 definition. Severe sepsis is defined as SIRS (sepsis) and the presence of sepsis-induced organ dysfunction defined by the 2012 SSC guidelines based on Sepsis-2. Following the new Sepsis-3 definitions alone will leave the expectations and practices for national coding and reporting requirements unmet. The national healthcare database will become inconsistent disrupting research, quality reporting and national healthcare trends and planning. Even sepsis screening, early identification and treatment that are the hallmarks of SSC may be impaired.

Of course ICD-10-CM and the OCG can be modified on October 1 each year, and this may very well happen, and we may eventually see corresponding changes from SSC, NQF and the IQR programs. It appears likely that following both the old Sepsis-2 and new Sepsis-3 definition may be necessary to accommodate these critical conflicts for now. Until such time when clear and consistent guidance is available, providers and institutions must make serious decisions about diagnosis, documentation, sepsis management guidelines, quality reporting and coding. References 1. Singer, M et al; The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA 2016; 315: 801-810. Accessed at http://jama.jamanetwork.com/issue.aspx 2. American College of Chest Physicians/Society of Critical Care Medicine Consensus Conference: definitions for sepsis and organ failure and guidelines for the use of innovative therapies in sepsis. Crit Care Med. 1992; 20:864-74. [PMID: 1597042] 3. Levy MM, Fink MP, Marshall JC, Abraham E, Angus D, Cook D, et al; SCCM/ESICM/ACCP/ATS/SIS. 2001 SCCM/ESICM/ACCP/ATS/SIS International Sepsis Definitions Conference. Crit Care Med. 2003; 31:1250-6. [PMID: 12682500] 4. Dellinger RP, Levy MM, Rhodes A, Annane D, Gerlach H, Opal SM, et al; Surviving Sepsis Campaign Guidelines Committee including the Pediatric Subgroup. Surviving sepsis campaign: international guidelines for management of severe sepsis and septic shock: 2012. Crit Care Med. 2013; 41:580-637. [PMID: 23353941] doi:10.1097/ccm.0b013e31827e83af 5. Surviving Sepsis Campaign. Updated Bundles in Response to New Evidence. 2015. Accessed at www.survivingsepsis.org/sitecollectiondocuments/ssc_bundle.pdf. 6. Surviving Sepsis Campaign Responds to Sepsis-3 (March 1, 2016). Accessed at http://www.survivingsepsis.org/sitecollectiondocuments/ssc-statements-sepsis- Definitions-3-2016.pdf