Sepsis as Seen by the CMO. Randy C. Roth, MD Chief Medical Officer

Transcription

1 Sepsis as Seen by the CMO Randy C. Roth, MD Chief Medical Officer 1

2 Challenges of Sepsis Sepsis, like many disease processes, is much more than a clinical challenge. For Hospitalists, we are treating the patient and the chart. The chart will control your physician profile, hospital income earned due to proper coding and documentation. Also, we would like to decrease mortality associated with sepsis. 2

3 Objectives Definition of Sepsis (Over the Years) Sever Sepsis and Septic Shock Sepsis Core Measure Confusion Surrounding Sepsis Criteria Denial Doldrums 3

4 What is Sepsis? A clinical syndrome characterized by an overwhelming systemic inflammatory response to an infection. 4

5 The systematic inflammatory response disrupts homeostasis through uncontrollable cascade: Excessive inflammation Hypercoagulation Fibrinolysis Microvascular Hypoperfusion Organ Dysfunction Increased Mortality 5

6 Common Manifestations of Sepsis Altered mental status( no no! ) including confusion, irritability and lethargy Bandemia Elevated CRP and/or pro-calcitonin Fever, chills, myalgias (temp >= F) Hyperglycemia in diabetes Elevated lactic acid Hypoventilation 6

7 Common Manifestations of Sepsis Hypoxemia Leukocytosis (and/or) wbc >=12,000 cells/mm 3 10% immature wbc, bands Positive blood culture for bacteria (not needed for Dx) Proteinuria Skin rash Tachycardia, > 90 BPM Tachypnea (respiratory alkalosis) (RR>=20 BPM) 7

8 Symptoms of Sepsis Shivering, fever, or very cold Extreme pain or general discomfort worst ever Pale or discolored skin Sleepy, difficult to wakeup, confused(elderly) I feel like I might die Short of breath 8

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10 Moving Target of Sepsis SCCM consensus definition was established. Many were educated that SIRS criteria equals sepsis Epidemiologically, saw sepsis rates double from , the most expensive disease treated in the United States was sepsis( not surprised) 10

11 Moving Target of Sepsis Hard to prove whether these activation cascades where prompted by infection or noninfection insult, like trauma or pancreatitis Claims data showed a large increase in sepsis codes, while pneumonia, uti, and cellulitis decreased More sensitive coding captured a wider but less ill group of patients, with an increased spend 11

12 Severe Sepsis / Septic Shock SCCM 2001 Severe Sepsis: This is still sepsis, but this degree of sepsis causes organs to malfunction and blood flow to become inadequate to parts of the body. Septic Shock: This is a worsening of severe sepsis, but now involves the circulatory system such as persistent hypotension which is refractory to volume resuscitation and requires a vasopressor. 12

13 Common Manifestations Seen in Severe Sepsis / Septic Shock Acute Failure: Liver, Renal or Respiratory ARDS Cold, clammy, grayish-blue (cyanotic) skin DIC Encephalopathy Hypoglycemia Hypophosphatemia Hypotension Hypothermia (temp <=96.8 F) 13

14 Common Manifestations Seen in Severe Sepsis / Septic Shock Increased cardiac output with a low systemic vascular resistance Increased O 2 consumption Leukopenia/leukemoid reaction, <= 4,000 cells/mm 3 Metabolic acidosis/lactic acidosis (due to impaired organ function); ph,7.30 and a plasma lactate >1.5 times the upper limit of normal Oliguria/decreased urine output, < 0.5 ml/kg/hr for 1 hour in the face of adequate intravascular volume or after adequate fluid challenge INR greater than 1.2 without explanation Shock Stupor, coma Thrombocytopenia, <100,00 platelets/mm 3 Remember: These manifestations need to be part of the medical record as evidence in the event the case is denied. 14

15 Mortality among Patients with Severe Sepsis, According the Number of SIRS Criteria Met

16 Mortality among Patients with Severe Sepsis. According to Status with Respect to Criteria for the Systemic Inflammatory Response Syndrome (SIRS)

17 SEPSIS-3 DEFINITION 17

18 The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis ) Sepsis: Life-threatening organ dysfunction caused by a dysregulated host response to infection. Organ dysfunction: An increase in the Sequential (Sepsis-Related) Organ Failure Assessment (SOFA) score of 2 or more points. An ACUTE change in total SOFA score >= 2 points secondary to the infection. 18

19 The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3) Septic shock: A subset of sepsis in which particularly profound circulatory, cellular, and metabolic abnormalities are associated with a greater risk of mortality than with sepsis alone. - vasopressor requirement to maintain a mean arterial pressure of 70 mm Hg or greater and serum lactate level greater than 2 mmol/l (.18 mg/dl) ) in the absence of hypovolemia. 19

20 SOFA: Sequential Organ Failure Assessment System Respiration Score PaO2/FiO2, mmhg (kpa) 400 (53.3) <400 (53.3) <300 (40) <200 (26.7) with respiratory support <100 (13.3) with respiratory support Coagulation Platelets, x103/μl 150 <150 <100 <50 <20 Liver Bilirubin, mg/dl (μmol/l (102- <1.2 (20) (20-32) (33-101) 204) >12.0 (204) Cardiovascular Central Nervous System MAP 70 mm Hg MAP <70 mm Hg Dopamine <5 or dobutamine (any dose) Dopamine or epinephrine 0.1 or norepinephrine 0.1 Dopamine >15 or epinephrine >0.1 or norepinephrine >0.1 Glasgow Coma Scale <6 score Renal Creatinine, mg/dl (μmol/ <1.2 (110) ( ) ( ) ( ) >5.0 (440) Urine output, ml/d <500 <200 20

21 qsofa Score (Quick SOFA) Used to identify patients with suspected infection who are at greater risk for a poor outcome outside the ICU Utilizes 3 criteria and assigns 1 point for: Low blood pressure (SBP <= 100 mmhg) High respiratory rate (>= 22 breaths per min) Altered mentation (Glasgow Coma Scale < 15) The score rages from 0 to 3 points Presence of 2 or more qsofa points near the onset of infection is associated with a greater risk of death or prolonged intensive care unit stay. 21

22 Case 1: Circa year male, hx of HTN, presents to ED with 2 day history of productive cough, SOB, fever Exam BP 110/70, HR 110, RR 26, Sat 92%, temp 102 F, LLL crackles and egophony Labs: WBC 20K, 11% Bands, Lactic Acid 1.8( did we check this then back?) Circa DX 1995 Pneumonia 2003 Sepsis ? Pneumonia again if sepsis, do we need to document Sofa or qsofa to avoid denial? 22

23 Case 2 70 y/o man with a history of HTN presents to the ED after a 2 day history of productive cough, SOB, and fever(101ºf). He is now confused, febrile, and in respiratory failure. PE: BP 70/30; P120; RR 30; Sats 98% (5LNCO2) Very uncomfortable with labored breathing Bronchial BS, egophony, and crackles in LLL Labs: WBC 20K, LA 6 mmol/l

24 Case 2 Circa DX 1995 Pneumonia 2003 Sepsis 2018 If document, qsofa score of 3, severe sepsis/septic shock Did our sepsis alert team document appropriate sepsis criteria, and can it be easily located in EMR? 24

25 Sepsis-3: Industry Statements The Journal of the American Medical Association, Sepsis-3 discarded the concept of SIRS as the basis for defining sepsis and eliminated the distinction between sepsis and severe sepsis The sepsis definitions used by CMS in SEP-1 sepsis management rely on sepsis as SIRS due to an infection and severe sepsis as sepsis with acute organ dysfunction; this WILL NOT CHANGE CMS will continue to track further research focusing on potential flaws in methods and statistical analysis and the need for prospective studies to substantiate the realworld clinical validity of the new Sepsis-3 definitions 25

26 Treatment of Sepsis Treatment of Sepsis Treat Infection Stabilize Hemodynamics Antibiotics Source Control Vasoactive Drugs Fluids

27 Duration of Hypotension before Effective Antimicrobial Therapy Retrospective cohort study of 2731 cases of septic shock in 14 ICU s across North America from 1989 to 2004 Data reviewed: Etiology of sepsis onset of hypotension time to appropriate antibiotics Outcomes Kumar et al. Crit Care Med 2006;34:

28 Duration of Hypotension before Effective Antimicrobial Therapy

29 Clinical Pearls In septic shock, the first few hours of care are critical for survival. Early Recognition Early Resuscitation Early administration of broad spectrum empiric antibiotics Usual Care by an expert physician in the first 6 hours is as good as Early Goal Directed Care

30 CMS IQR: SEPSIS CORE MEASURES 30

31 Sepsis Bundle Project Patients: 18 and over With a PRINCIPLE or OTHER Diagnosis code of: Sepsis Severe Sepsis Septic Shock 31

32 Sepsis Bundle Project Severe Sepsis Provider documentation of a suspected source of clinical infection Two or more SIRS criteria Organ dysfunction, evidenced by any one of the following: SBP < 90 or MAP <65 or a systolic BP decrease of more than 40 points Creatinine > 2.0 or urine output <0.5 mg/kg/hr for 2 hours Bilirubin > 2 mg/dl Platelet count < INR > 1.5 or PTT > 60 sec Lactate >2.0 mmol/l 32

33 Sepsis Bundle Project Septic Shock: Provider documentation of severe sepsis AND Tissue hypoperfusion persists in the hour after crystalloid fluid administration, evidenced by ONE of the following: SBP < 90 MAP < 65 Decrease in SBP by > 40 points Lactate level >

34 Sepsis Key Concepts Key concepts of the measure: The time of presentation (TOP) Patient meeting criteria Severe Sepsis Septic Shock 34

35 Sepsis Key Concepts Severe Sepsis: Completed Within 3 Hours TOP Requirements: Draw lactate level, repeat in 6 hrs if > 2 Draw blood cultures x 2 (4 bottles) BEFORE antibiotics Administer broad-spectrum antibiotics Piperacillin/tazobactam Imipenem Levofloxin Administer 30 ml/kg IV fluids (NS,LR) for hypotension or lactate >= 4 mmol/l or >= 36 mg/dl 35

36 SEPSIS BUNDLE 36

37 CMS: SEP-1 Sepsis Guidelines Severe sepsis is defined as sepsis plus a lactate > 2 or evidence of organ dysfunction You need to meet ALL the measures in order to be compliant with this core measure Patients with septic shock require an assessment of volume status and tissue perfusion within 6 hours of presentation Patients NOT included are those transferred from another facility or those placed on comfort care. 37

38 CODING CLINIC ADVICE 38

39 Sepsis-3: Industry Statements 39

40 DENIAL DOLDRUMS 40

41 ESCAPE the Doldrums Evaluate the denial. Search the denial/document letter. Coding accuracy Assess the clinical validity of the diagnosis. Physician involvement. Escalation policy. 41

42 Evaluate the Denial Review to determine if the denial is clinical or coding based and refer appropriately. Assess the tone of the denial. Look for the overall assumptions of the denial. Review for any clinical references to infer the basis of the denial. (SOFA,SIRS,Both,Neither) Check contract for specifics if possible. 42

43 Search: Denial Document for Each Item Identified Make a list of the assumptions identified in the denial letter If the basis of the denial is listing only one lab result or one vital sign, consider the trends. If coding is in question, review for the specifics. If denial documents has indication of lack of consistent documentation throughout the record, consider findings of documented evidence for sepsis( DC summary doesn t support the H and P). Look for terminology missing in the denial document that could potentially be a symptom of overall diagnosis of sepsis. Create a checklist using known clinical criteria for sepsis and compare what is in the letter versus what is documented in the record. 43

44 Coding Accuracy List all code numbers mentioned in the denial document. Review the coding summary for overall accuracy of the coding on the case. Review for citation of coding guidelines or Coding Clinic to support conclusions. Determine all coding reference material to support codes selected, including coding handbook, coding guidelines, Coding Clinic, and other material as appropriate. 44

45 Assess: Clinical Validity of Sepsis Using previously referenced checklist of clinical criteria for sepsis, determine if the case meets the clinical validity of sepsis. Determine if the sepsis was not consistently documented and was potentially a differential diagnosis in the ED/H&P and was later just not mentioned again. Determine if a query should have been generated to obtain clarification of the diagnosis prior to coding. Compare the clinical criteria to an hospital-established criteria for sepsis. 45

46 Physician Involvement: Key to Success Determine what level of physician involvement is needed in the denial process. Include a physician summary of the case and supporting factors, including one from the attending physician. Present denial records to the clinical review of denials committee that includes physicians. Establish physician sepsis criteria and compare the case to those criteria. Involve infectious disease department and sepsis team if applicable. 46

47 Escalation Policy : Essential to Allow Path for Denial Review All sepsis cases should go through a second-level review process to determine clinical validity of the diagnosis. If sepsis criteria has been established by the hospital/system, charts should be compared to those criteria. Charts with sepsis documented but not meeting criteria should be referred to a physician advisor/reviewer prior to billing. Physician management should be included in report out of denial cases. 47

48 Example of Denial Wording It was noted that the physician documented sepsis due to pneumonia in the chart. To validate sepsis, the medical record is examined for consistent documentation of the condition; evidence that the patient's presentation cannot be explained by the local infection alone or by a non-infectious condition; and evidence of organ dysfunction caused by a dysregulated inflammatory response to infection. SIRS parameters represent a normal physiologic response to infection and are not a specific indication of sepsis. While the patient s presentation warranted consideration of sepsis as a possible diagnosis and a localized infection of pneumonia was identified, upon investigation, the diagnosis of sepsis was not supported by the clinical evidence. The patient exhibited a fever and an elevated white blood cell count of 25.6 which could be explained by a normal physiological response to an infection. The patient did not exhibit any evidence of organ dysfunction or hemodynamic compromise related to infection. There was insufficient clinical evidence and supportive documentation in the records available for review to substantiate the coding of this condition. 48

49 Elements of a Letter to Overturn Case All Documented vital signs and notes were mentioned, including: Chills Hazy airspace disease in left lung Trending of tachycardia in Leukocytosis of 25.6, 31.5 and 17.7 High lactic acid 18.9 Vancomycin, Cefepime, and Zithromax Yeast in respiratory culture Paragraph detailing additional signs and symptoms of sepsis Encephalopathy 9 Reference Coding guidelines with actual citation of specific clinical reference criteria Diagnostic criteria for lactate abnormalities Sepsis 2 criteria were cited. 49

50 Denial Letter Format Rebuttal summary. Evidence to support coding of case. Physician summary of clinical indicators of sepsis, including end-organ involvement if applicable. Specific information based on denial document. Clinical reference information to support position. Copy to contact if applicable. Coding Clinics to support position. 50

51 Attachment to Denial Letters for Reference AHA Coding Clinic for ICD-10, Fourth Quarter 2016 Pages: SEPSIS Rapid Response Team evaluation form. Sepsis criteria for the hospital. Coding guidelines detailing sepsis reporting. Clinical reference information used in decision. 51

52 Summary: Clinical vs Administrative Data The definition of Sepsis continues to change in the eyes of clinicians, coders, and payors. The most recent publications of new sepsis and sepsis shock management have added even more uncertainty to establishing a clear set of criterion that enables early detection, while avoiding immature diagnoses that lead to unnecessary care. (Severe Sepsis Diagnosis with an LOS of 2.0) Leaders must continue to define sepsis with a clear cut criteria applicable to all patients independent of payor source. 52