American College of Emergency Physicians (ACEP) Clinical Emergency Data Registry (CEDR) Quality Measures. Status: For Public Comment- July 27, 2015

Transcription

1 1 American College of Emergency Physicians (ACEP) Clinical Emergency Data Registry (CEDR) Quality Measures Status: For Public Comment- July 27, 2015 Obsolete after August 21, 2015

2 2 Table of Contents Disclaimer Clinical Emergency Data Registry Overview Quality Measures Technical Expert Panel Objectives & Acknowledgments Quality Measures Technical Expert Panel Roster Purpose of Measurement Set Harmonization of the Measurement Set Guide to Reading the Data Requirements Table (DRT) Measure #1: Sepsis Management: Lactate Level Measurement Accountability measure Measure #2: Sepsis Management: Blood Cultures Ordered Quality Improvement measure Measure #3: Sepsis Management: Antibiotics Ordered Accountability measure Measure #4: Sepsis Management: Fluid Resuscitation Accountability measure Measure #5: Sepsis Management: Repeat Lactate Level Measurement Accountability measure Intermediate Outcome Measure #6: Sepsis Management: Lactate Clearance Rate 10% Accountability measure Measure #7: Appropriate Foley Catheter Use in the Emergency Department Accountability measure Measure #8: Appropriate Use of Imaging for Recurrent Renal Colic Quality Improvement measure Additional Measure Recommended for Use with this Measure Set References for All Measures Page

3 3 Disclaimer Physician Performance Measures (Measures) and related data specifications developed by the American College of Emergency Physicians (ACEP) are intended to facilitate quality improvement activities by physicians. These measures are intended to assist physicians in enhancing quality of care. These Measures are not clinical guidelines and do not establish a standard of medical care, and have not been tested for all potential applications. ACEP encourages testing and evaluation of its Measures. Measures are subject to review and may be revised or rescinded at any time by ACEP. The measures may not be altered without prior written approval from ACEP. Commercial use is defined as the sale, license, or distribution of the measures for commercial gain, or incorporation of the measures into a product or service that is sold, licensed, or distributed for commercial gain. Commercial uses of the measures require a license agreement between the user and ACEP. Neither ACEP nor its members shall be responsible for any use of the measures. THESE MEASURES AND SPECIFICATIONS ARE PROVIDED AS IS WITHOUT WARRANTY OF ANY KIND. Limited proprietary coding is contained in the Measure specifications for convenience. Users of the proprietary code sets should obtain all necessary licenses from the owners of these code sets. The AMA, PCPI, and its members disclaim all liability for use or accuracy of any Current Procedural Terminology (CPT ) or other coding contained in the specifications. CPT contained in the Measure specifications is copyright American Medical Association. LOINC copyright Regenstrief Institute, Inc. This material contains SNOMED Clinical Terms (SNOMED CT ) copyright International Health Terminology Standards Development Organisation. ICD-10 copyright 2014 World Health Organization. All Rights Reserved.

4 4 Clinical Emergency Data Registry Overview The American College of Emergency Physicians (ACEP) is committed to providing the highest quality emergency care and optimizing health outcomes for all patients. In doing so, ACEP has developed the Clinical Emergency Data Registry (CEDR), which was deemed by the Center for Medicaid and Medicare Services (CMS) as a qualified clinical data registry (QCDR) for the 2015 performance year. CEDR is the first Emergency Medicine specialty-wide registry at a national level, designed to measure and report healthcare quality and outcomes. It will also provide data to identify practice patterns, trends and outcomes in emergency care. CEDR is an evolving registry, which will support emergency physicians efforts to improve quality and practice in all types of emergency departments even as practice and payment policies change over the coming years. A main objective of CEDR is to help emergency physicians and clinicians meet both the Centers for Medicare and Medicaid Services Physician Quality Reporting System (PQRS) reporting and potentially regional and national certification requirements. Finally, CEDR will provide data to identify practice patterns, trends, and outcomes in emergency care. Goals of CEDR Provide a unified method for ACEP members to collect and submit Physician Quality Reporting System (PQRS) data, Maintenance of Certification (MOC), Osteopathic Continuous Certification (OCC), Ongoing Professional Practice Evaluation (OPPE), outcome data, and other related or applicable quality and patient safety data to meet quality improvement and regulatory requirements Promote the highest quality of emergency care for patients Demonstrate the value of emergency care Facilitate appropriate emergency care research Benefits of CEDR Increased Medicare revenue (up to 6% for the 2015 performance year) Potentially increased revenue from private payers Participation can cover all quality measure reporting requirements TJC OPPE/ Focused Professional Practice Evaluation (FPPE) compliance MOC Part IV activities (in conjunction with an American Board of Emergency Medicine [ABEM] approved MOC program) and MOL activities For more information on CEDR, please visit

5 5 Quality Measures Technical Expert Panel Objectives The ACEP Board of Directors approved the development of quality measures in January 2015 with the following objectives: To develop, specify, maintain, and recommend quality measures for the Clinical Emergency Data Registry (CEDR); To continue the ongoing cyclical work of evaluating and maintaining current portfolio of CEDR accountability measures for CMS reporting programs. To identify areas for internal quality improvement through MOC Part IV, OPPE, and other QI and data collection activities for important topics. Acknowledgement This measure set was made possible in part by the generous support of the American Board of Emergency Medicine (ABEM). Quality Measures The American College of Emergency Physicians (ACEP) convened a Quality Measures Technical Expert Panel (TEP) to assess opportunities for the development of evidence-based performance measures for ACEP s Clinical Emergency Data Registry (CEDR). The ACEP Quality Measures TEP proposes this set of registry measures to promote evidence-based medicine and address gaps in care around emergency medicine with a focus on sepsis management and efficiency in the emergency department.

6 6 Quality Measures Technical Expert Panel Roster Chair Arjun Venkatesh, MD, MBA Vice-Chair Jeremiah D. Schuur, MD, MHS, FACEP Quality & Performance Committee Chair Stephen V. Cantrill, MD, FACEP Qualified Clinical Data Registry Chair Steve Epstein, MD, FACEP Board Liaison James Augustine, MD, FACEP American College of Emergency Physicians Robert I. Broida, MD, FACEP Kathleen Brown, MD, FACEP Vidor E. Friedman, MD, FACEP Michael Granovsky, MD, FACEP Timothy C. Hsu, MD, FACEP Chris Moore, MD, FACEP Michael P. Phelan, MD FACEP William E Reisinger, III, DO, FACEP Paul Sierzenski, MD, RDMS, FACEP L. Kendall Webb, MD, FACEP American College of Emergency Physicians Sepsis Expert Panel Michael Filbin, MD, FACEP David Huang, MD, MPH, FACEP Alan Jones, MD, FACEP Jack Kelly, DO, FACEP Tiffany Osborn, MD, FACEP John Rogers, MD, FACEP Todd Slesinger, MD, FACEP Scott Weingart, MD, FACEP Jessica Whittle, MD, PhD, FACEP Donald Yealy, MD, FACEP American Academy of Family Physicians Andrew Eisenberg, MD, MHA American Academy of Neurological Surgeons David Okonkwo, MD, PhD American Academy of Neurology Steven Mandel, MD, FAAN American Board of Emergency Medicine Michael L Carius, MD, FACEP Terry Kowalenko, MD, FACEP Robert Philip Wahl, MD, FACEP American College of Radiology/ American College of Neuroradiology Ari Blitz, MD Judy Burleson, MHSA (Staff) Marta Heilbrun, MD, MS Emergency Nurses Association Ann Marie Papa, DNP, RN, CEN, FAEN, FAAN The Joint Commission Kathleen Domzalski, RN, BS, MHSA

7 7 AMA-PCPI Consultants Yvette Apura, RHIA Seth Blumenthal, MBA Elizabeth Bostrom, MPH Kendra Hanley, MS Meredith Jones, MPH Jamie Jouza, MBA Toni Kaye, MPH Kimberly Smuk, RHIA Samantha Tierney, MPH ACEP Staff Dainsworth Chambers Marta Foster Victoria Purcell Margaret Montgomery Stacie Schilling Jones, MPH David McKenzie

8 8 Purpose of Measurement Set The American College of Emergency Physicians (ACEP) convened a multi-disciplinary stakeholder technical expert panel (TEP) to identify and develop quality measures for the purpose of establishing ACEP s Clinical Emergency Data Registry (CEDR). The goal of CEDR is to improve outcomes and quality of care provided to patients in the emergency department (ED). The TEP was tasked with developing registry measures that reflect the most rigorous clinical evidence and address areas most in need of performance improvement. The TEP considered opportunities for outcome, process and structural measures centered on appropriate management of sepsis and efficiency of care in the ED. The first six measures represent the critical steps and appropriate management of sepsis as detailed in the Surviving Sepsis Campaign clinical practice guidelines and include an intermediate outcome measure of the effectiveness of care provided in those critical steps. The intent of the sepsis measures is to highlight those opportunities for individual emergency department physicians to impact sepsis care. Together, the first six measures provide a broad, evidence-based view of the quality of sepsis management in the ED. For the current implementation of these measures, the aim is to focus on the completion of these critical steps during the patient s ED visit. The final two measures in the set focus on key opportunities to improve the efficiency of care provided in the ED and reduce overuse of inappropriate services. The measures in this set are intended to establish baseline performance of individual emergency department physicians. As these measures are implemented through CEDR, future iterations will be shaped by the emergency department physician performance data that is collected. Similarly, data from CEDR s base year will inform ACEP s participation in CMS group practice reporting options (GPRO) for QCDRs and opportunities to harmonize measures.

9 9 Harmonization of the Measurement Set As existing hospital-level or plan-level measures are available for the same measurement topics, attempts to harmonize the measures to the extent feasible were considered during the development process. The ACEP CEDR sepsis management measures are similar to NQF 0500: Severe Sepsis and Septic Shock: Sepsis Management Bundle and CMS IQR SEP-1: Early Management Bundle, Severe Sepsis/Septic Shock. NQF 0500 and CMS SEP-1 are specified for use at the hospital-level and the ACEP measures presented in this measurement set are for use at the provider-level. Differences in the denominator measure language and level of measurement are presented by measure steward in Table 1. Sepsis Measure s and Level of Measurement by Measure Steward. As the ACEP CEDR measures evolve based on data collected in the base year, the opportunity for harmonization and alignment with other sepsis denominators will be visited. Please see individual measure documentation for additional information regarding measure harmonization. Table 1. Sepsis Measure s and Level of Measurement by Measure Steward Measure Steward Language of Sepsis Measures Level of Measurement American College of Emergency Physicians (ACEP) Clinical Emergency Data Registry (CEDR) National Quality Forum (NQF) 0500: Severe Sepsis and Septic Shock: Sepsis Management Bundle Center for Medicare and Medicaid Services (CMS) SEP-1: Early Management Bundle, Severe Sepsis/Septic Shock All emergency department visits for patients aged 18 years and older with septic shock For purposes of this measure, patients with septic shock will be identified with any of the following criteria: Diagnosis of septic shock Diagnosis of sepsis and hypotension Diagnosis of infection and hypotension Number of patients presenting with severe sepsis or septic shock. Inpatients age 18 and over with an Principal or Other Diagnosis Code of Sepsis, Severe Sepsis, or Septic Shock Included Populations: Discharges age 18 and over with an Principal or Other Diagnosis Code of Sepsis, Severe Sepsis, or Septic Shock Eligible Provider (EP) Eligible Hospital (EH), Facility, Integrated Delivery System Eligible Hospital (EH)

10 10 Guide to Understanding the Format and Information Included in the Data Requirements Table (DRT) The purpose of the Data Requirements Table (DRT) is to identify each of the data elements that will be needed to capture the measure, including the required attributes of each data element. The DRT does not include the Boolean logic (AND, OR, AND NOT) that is used to combine the data elements to form the measure components (Initial Population,, Exclusions, Numerator, and Exceptions) based on the measure s clinical intent. Once the measures and DRTs have been finalized, then the Health Quality Measures Format (HQMF) emeasure, which includes the logic, will be developed. Definitions for each column, from left to right, included in the DRT: Measure Component Measure Component identifies where in the measure the data element is located. For proportion measures the possible options include: Initial Population,, Exclusions, Numerator or Exceptions. Supplemental Data Elements are also included in the measure component column, and applicable to all measures. The supplemental data elements include administrative sex, race, ethnicity, and payer, and are recommended to be collected for purposes of stratifying measure results. Additional information regarding the supplemental data elements can be found within the CMS Measures Management System Blueprint at: Instruments/MMS/MeasuresManagementSystemBlueprint.html Quality Data Model (QDM) Category All data elements used in quality measures are classified according to the QDM, the data model used to specify electronic clinical quality measures (ecqms). When defining a QDM element, the QDM category is the highest level of definition. There are 19 different QDM categories in the data model, including Medication, Procedure, and Diagnostic Study. Complete documentation for the Quality Data Model can be accessed at: Quality Data Model (QDM) Datatype The QDM datatype provides the context in which each category is used to describe a part of the clinical care process. Examples of the QDM datatypes include Diagnosis, Active and Procedure, Performed as they are applied to the Condition/Diagnosis/Problem and Procedure categories, respectively. Value Set Name The Value Set Name is the title of the list of clinical concepts, or codes, that are used to represent a data element used in a quality measure. Considerations and best practices for naming a value set so that it is in alignment with the intent and purpose of the data element are located at: Occurrence A is periodically used in the Value Set Name column to further define the Data Element, indicating a specific instance of that data element. Occurrence A allows a specific instance of that data element to be used across

11 11 multiple measure components in the measure, or used multiple times within the same measure component, and in order to meet the intent of the measure, it needs to be the same specific instance. Standard Terminology The Standard Terminology identifies the coding system used to specify the value set. In the DRT, only the name of the standard terminology is included; specific clinical concepts (or codes) are not included. Examples of the standard terminologies used in emeasures include, LOINC, CPT, and. The standard terminology selected to represent a value set follows the vocabulary recommendations that have been designated by the ONC Health IT Standards Committee (HITSC) for each QDM category. Both the transition vocabularies and the clinical vocabularies that were recommended by the HITSC are included in the DRT. More information about how these terminologies were selected is available at: A designation is used in this column to indicate that in addition to the individual value sets, there will be another value set that will serve as a wrapper for the individual value set(s) used to specify the data element. It groups together value sets that represent that same umbrella data element. For example, the individual value sets for Sepsis in,, and are wrapped together in a grouping value set. OID OID is an acronym used for object identifier and can be thought of as a numeric label used to represent the value set. Individual value sets and value sets all have a unique OID. Where the information included in the OID column is listed as, it means that the OID has not yet been assigned. OIDs that have been populated represent existing value sets that are currently available in the National Library of Medicine Value Set Authority Center (NLM VSAC). Constraints The Constraints column identifies the temporal operators, and the relationship between the data element being specified and another data element(s) in the measure. The temporal operators are used to connect two data elements included in the measure. Three examples of temporal operators include overlaps, starts during, and starts before end of. The QDM documentation available at includes a complete list of the available temporal operators and their corresponding definitions. Here is an example of how the temporal operators and the data element relationships are combined together and presented in the Constraints column. Data Element A starts during Data Element B. The Constraints column will include the italicized information (temporal operator and Data Element B). In instances where the term, Occurrence A is used in the Constraints column to further define Data Element B; the intent of Occurrence A is to refer to a specific instance of Data Element B.

12 12 Comments/Rationale Additional comments relevant to the data element being specified are included in the Comments/Rationale column. During public comment, we have included some specific questions in the Comments/Rationale column. We appreciate responses to the specific questions as they will inform the final specifications of the measures. How to use the information presented in the DRT to understand the intent of the data element: In general, each data element included in the DRT is represented in a single row. Should a data element have additional attributes that are to be applied to it, then an additional row will be added. This can be easily identified by the Attribute entry in the QDM Category column; a note is included in the Comments/Rationale column that names the data element to which a given attribute is applied. Example: Sepsis Sepsis is a diagnosis that will be specified using,, and standard terminologies. It is used in the initial population of the measure, and in order to meet inclusion in the initial population, the active diagnosis of Sepsis needs to start during the Emergency Department Visit.

13 13 Measure Description MEASURE #1: Sepsis Management: Lactate Level Measurement Percentage of emergency department visits for patients aged 18 years and older with septic shock who had a serum lactate level ordered during the emergency department visit Measure Components Numerator Statement Statement Exclusions Emergency department visits for patients who had a serum lactate level ordered during the emergency department visit All emergency department visits for patients aged 18 years and older with septic shock For purposes of this measure, patients with septic shock will be identified with any of the following criteria: Diagnosis of septic shock Diagnosis of sepsis and hypotension Diagnosis of infection and hypotension Patients with any of the following: Transferred into the emergency department from another acute care facility or other in-patient hospital setting Left before treatment was complete Died during the emergency department visit Cardiac arrest within the emergency department visit Patient or surrogate decision maker declined care Advanced directives present in patient medical record for comfort care Toxicological emergencies Burn Seizures Primary diagnosis of o Gastrointestinal bleeding o Stroke o Acute myocardial infarction o Acute trauma Exceptions Rationale for the Measure Supporting None As soon as patients presenting to the emergency department with sepsis- induced tissue hypoperfusion are identified, protocolized, quantitative resuscitation is recommended. Early resuscitation strategies, including evidence-based treatments to normalize elevated lactate, are associated with improved survival rates in emergency department patients. 1 In order to achieve lactate normalization in patients with elevated levels, an initial lactate measurement must be obtained. The following evidence statements are quoted verbatim from the referenced clinical

14 14 Guideline guidelines and other references: Measure Importance Relationship to Desired Outcome Surviving Sepsis Campaign: International Guidelines for Management of Severe Sepsis and Septic Shock 2012 We recommend routine screening of potentially infected seriously ill patients for severe sepsis to increase the early identification of sepsis and allow implementation of early sepsis therapy (grade 1C). 1 Surviving Sepsis Campaign 3-Hour Bundle Measure Lactate Level. Obtaining a lactate level is essential to identifying tissue hypoperfusion in patients who are not yet hypotensive but who are at risk for septic shock. 2 An association between elevated lactate with morbidity and mortality in diverse populations of critically ill patients including patients with septic shock. 3 Clinically, patients with sepsis experience elevated serum lactate due to impaired clearance or excessive production of lactate manifested by a dysfunction in the hepatic, renal, and other organ functions. For patients presenting to the emergency department with sepsis, a measurement of serum lactate is a suitable and timely strategy for confirming patients atrisk for poor outcomes and initiating treatment. 4 Opportunity for Improvement Related Measures Obtaining a lactate level is associated with improved outcomes in patients with sepsis as it is critical to identifying tissue hypoperfusion in patients who are not yet hypotensive but who are at risk for severe sepsis or septic shock. 4 In a large-scale, multicenter study of compliance with the Surviving Sepsis Campaign guidelines, only 61% of patients had an initial lactate value measured in the first quarter of the study. In the final quarter, only 78.7% of patients had an initial lactate measurement. 5 Staff has considered harmonization with CMS Hospital Inpatient Quality Reporting (IQR): Sepsis Bundle and NQF #0500: Severe Sepsis and Septic Shock Management Bundle Measure Designation Type of measure National Quality Strategy Priority/CMS Measure Domain (check all that apply) Process Outcome Structure Clinical Process-Effectiveness Patient Safety Patient Experience Care Coordination Efficiency: Overuse Efficiency: Cost Population & Community Health Level of Individual clinicians Measurement Clinician groups

15 15 (check all that apply) Additional Data Elements Hospital Outpatient/ED Additional data elements for collection in the American College of Emergency Physician s Clinical Emergency Data Registry (CEDR) are described here. These data elements include: Diagnosis of severe sepsis Diagnosis of organ dysfunction Triage start date and time Provider contact date and time Treatment space date and time Disposition order from ED date and time ICU admission date and time OR admission date and time Serum lactate measurement collection start date and time Serum lactate measurement result

16 Data Requirements Table Measure #1: Sepsis Management: Lactate Level Measurement 16 Measure Component QDM* Category QDM* Datatype Value Set Name Standard Terminology OID Constraints Comments/Rationale Supplemental Data Elements Individual Characteristic Patient Characteristic ONC Administrative Sex Administrative Sex (HL7 v2.5) during measurement period Individual Characteristic Patient Characteristic Race CDC during measurement period Individual Characteristic Patient Characteristic Ethnicity CDC during measurement period Individual Characteristic Patient Characteristic Payer Source of Payment Typology during measurement period This data element is collected for the purpose of stratifying results in an effort to highlight disparities. This data element is collected for the purpose of stratifying results in an effort to highlight disparities. This data element is collected for the purpose of stratifying results in an effort to highlight disparities. This data element is collected for the purpose of stratifying results in an effort to highlight disparities. Measure Timing n/a Measurement Period n/a n/a by Measure Implementer Initial Population Individual Characteristic Patient Characteristic Age Calculation n/a Measurement start date minus Birth Date must be greater than or equal to > = 18 years AT Measurement Period 18 years For the purposes of this measure, 'Emergency Department Visit' is defined Encounter Encounter, Performed Emergency Department Visit, Occurrence A CPT during Measurement Period as the arrival time through the departure time according to EDBA consensus definitions (Wiler et al. 2015) Condition/Diagnosis/Problem Diagnosis, Active Infection Condition/Diagnosis/Problem Diagnosis, Active Acute Hypotension Condition/Diagnosis/Problem Diagnosis, Active Sepsis Condition/Diagnosis/Problem Diagnosis, Active Septic Shock Equals Initial Population Transfer of Care Transfer From Inpatient Facility starts before end of [Occurrence A of Encounter, Transfer of Care Transfer From Acute Care Facility starts before end of [Occurrence A of Encounter, Encounter Encounter, Performed Emergency Department Visit, Occurrence A CPT during Measurement Period For the purposes of this measure, 'Emergency Department Visit' is defined as the arrival time through the departure time according to EDBA consensus definitions (Wiler et al. 2015). This attribute is applied to the value set titled 'Emergency Department Visit'. This value set includes the concepts related to 'left against medical advice' and 'left before treatment completion', either with or without an intervention. Exclusions Attribute Attribute: discharge status Left Before Treatment Completion n/a - Patient left before treatment completion (LBTC) - Patient left before being seen (LBBS) - Patient left before being seen without intervention (LBBS NI) - Patient left before being seen with intervention (LBBS WI) - Patient left subsequent to being seen (LSBS) (Wiler et al. 2015) Attribute Attribute: discharge status Patient Expired n/a This attribute is applied to the value set titled 'Emergency Department Visit'. Condition/Diagnosis/Problem Diagnosis, Active Cardiac Arrest Intervention Intervention, Order Comfort Measures American College of Emergency Physicians. All Rights Reserved. Quality Data Model (QDM), Version 4.1.2

17 Data Requirements Table Measure #1: Sepsis Management: Lactate Level Measurement 17 Measure Component QDM* Category QDM* Datatype Value Set Name Standard Terminology OID Constraints Comments/Rationale Intervention Intervention, Performed Comfort Measures Communication Communication: Patient to Provider Declined Care Condition/Diagnosis/Problem Diagnosis, Active Burn We seek public comment on the appropriate population of burn patients who should be excluded from this measure. Condition/Diagnosis/Problem Diagnosis, Active Seizure Condition/Diagnosis/Problem Diagnosis, Active Toxicological Emergency This value set includes the concept of metformin toxicity. We seek public comment on what other toxicological emergencies are relevant to these measures and should be included in this value set. Exclusions Condition/Diagnosis/Problem Diagnosis, Active Gastrointestinal Bleeding Condition/Diagnosis/Problem Diagnosis, Active Stroke Condition/Diagnosis/Problem Diagnosis, Active Myocardial Infarction Condition/Diagnosis/Problem Diagnosis, Active Acute Trauma Attribute Attribute: Ordinality Principal n/a This attribute determines that a diagnosis was the principal diagnosis for the 'Emergency Department Visit' and is applied to the value sets titled 'Gastrointestinal Bleeding', 'Stroke', 'Myocardial Infarction', and 'Acute Trauma'. Numerator Laboratory Test Laboratory Test, Order Serum Lactate LOINC during [Occurrence A of Encounter, Performed: Exceptions There are no valid denominator exceptions 2015 American College of Emergency Physicians. All Rights Reserved. Quality Data Model (QDM), Version 4.1.2

18 18 Measure Description MEASURE #2: Sepsis Management: Blood Cultures Ordered This measure is intended for Quality Improvement reporting purposes. Percentage of emergency department visits for patients aged 18 years and older with septic shock who had a blood culture ordered during the emergency department visit Measure Components Numerator Statement Statement Exclusions Emergency department visits for patients who had a blood culture ordered during the emergency department visit All emergency department visits for patients aged 18 years and older with septic shock For purposes of this measure, patients with septic shock will be identified with any of the following criteria: Diagnosis of septic shock Diagnosis of sepsis and hypotension Diagnosis of infection and hypotension Patients with any of the following: Transferred into the emergency department from acute care facility or other inpatient hospital setting Left before treatment was complete Died during the emergency department visit Cardiac arrest within the emergency department visit Patient or surrogate decision maker declined care Advanced directives present in the patient medical record for comfort care Toxicological emergencies Burn Seizures Primary diagnosis of: o Gastrointestinal bleeding o Stroke o Acute myocardial infarction o Acute trauma Exceptions Rationale for the Measure None In order to identify the origin of infection in critically ill septic shock patients, blood cultures should be ordered to guide the course and type of antibiotics used against harmful pathogens for treatment. The failure to order a blood culture during the emergency department visit may impact the appropriate identification and growth of bacteria which is associated with an increase in negative health outcomes to the patient including death.

19 19 This measure is intended for quality improvement reporting. The collection of blood cultures is a critical step in the treatment of sepsis but is not exclusively attributed to the action of the emergency department physician. Supporting Guideline The following evidence statements are quoted verbatim from the referenced clinical guidelines and other references: Measure Importance Surviving Sepsis Campaign: International Guidelines for Management of Severe Sepsis and Septic Shock 2012 We recommend routine screening of potentially infected seriously ill patients for severe sepsis to increase the early identification of sepsis and allow implementation of early sepsis therapy (grade 1C). We recommend 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 (grade 1C). 1 Relationship to Desired Outcome Opportunity for Improvement Related Measures Blood cultures are effective in identifying the specific infecting organism in septic shock patients and guiding the antibiotic regimen used in treatment. 2 Customization of antibiotic treatment, following the order of the blood culture, is associated with numerous benefits to the patient including reduction in exposure to: unnecessary antibiotics, drug-resistant organisms, complications with antibiotic use, allergies, and drug reactions. 1 A prospective multi-center observational study found that compliance with the Surviving Sepsis Campaign 2012 guidelines recommendation to draw blood cultures before antibiotics were administered was only in the range of 54.4 to 64.5%. 6,7 Staff has considered harmonization with CMS Hospital Inpatient Quality Reporting (IQR): Sepsis Bundle and NQF #0500: Severe Sepsis and Septic Shock Management Bundle Measure Designation Type of measure National Quality Strategy Priority/CMS Measure Domain (check all that apply) Level of Measurement Process Outcome Structure Clinical Process-Effectiveness Patient Safety Patient Experience Care Coordination Efficiency: Overuse Efficiency: Cost Population & Community Health Individual clinicians

20 20 (check all that apply) Additional Data Elements Clinician groups Hospital Outpatient/ED Additional data elements for collection in the American College of Emergency Physician s Clinical Emergency Data Registry (CEDR) are described here. These data elements include: Diagnosis of severe sepsis Diagnosis of organ dysfunction Triage start date and time Provider contact date and time Treatment space date and time Disposition order from ED date and time ICU admission date and time OR admission date and time Blood culture collection start date and time Blood culture result Blood culture ordered prior to the order of antibiotics

21 Data Requirements Table Measure #2: Sepsis Management: Blood Cultures Ordered 21 Measure Component QDM* Category QDM* Datatype Value Set Name Standard Terminology OID Constraints Comments/Rationale Supplemental Data Elements Individual Characteristic Patient Characteristic ONC Administrative Sex Administrative Sex (HL7 v2.5) during measurement period Individual Characteristic Patient Characteristic Race CDC during measurement period Individual Characteristic Patient Characteristic Ethnicity CDC during measurement period Individual Characteristic Patient Characteristic Payer Source of Payment Typology during measurement period This data element is collected for the purpose of stratifying results in an effort to highlight disparities. This data element is collected for the purpose of stratifying results in an effort to highlight disparities. This data element is collected for the purpose of stratifying results in an effort to highlight disparities. This data element is collected for the purpose of stratifying results in an effort to highlight disparities. Measure Timing n/a Measurement Period n/a n/a by Measure Implementer Initial Population Individual Characteristic Patient Characteristic Age Calculation n/a Measurement start date minus Birth Date must be greater than or equal to > = 18 years AT Measurement Period 18 years For the purposes of this measure, 'Emergency Department Visit' is defined Encounter Encounter, Performed Emergency Department Visit, Occurrence A CPT during Measurement Period as the arrival time through the departure time according to EDBA consensus definitions (Wiler et al. 2015) Condition/Diagnosis/Problem Diagnosis, Active Infection Condition/Diagnosis/Problem Diagnosis, Active Acute Hypotension Condition/Diagnosis/Problem Diagnosis, Active Sepsis Condition/Diagnosis/Problem Diagnosis, Active Septic Shock Equals Initial Population Transfer of Care Transfer From Inpatient Facility starts before end of [Occurrence A of Encounter, Transfer of Care Transfer From Acute Care Facility starts before end of [Occurrence A of Encounter, Encounter Encounter, Performed Emergency Department Visit, Occurrence A CPT during Measurement Period For the purposes of this measure, 'Emergency Department Visit' is defined as the arrival time through the departure time according to EDBA consensus definitions (Wiler et al. 2015). This attribute is applied to the value set titled 'Emergency Department Visit'. This value set includes the concepts related to 'left against medical advice' and 'left before treatment completion', either with or without an intervention. Exclusions Attribute Attribute: discharge status Left Before Treatment Completion n/a Patient left before treatment completion (LBTC) - Patient left before being seen (LBBS) - Patient left before being seen without intervention (LBBS NI) - Patient left before being seen with intervention (LBBS WI) - Patient left subsequent to being seen (LSBS) (Wiler et al. 2015) Attribute Attribute: discharge status Patient Expired n/a This attribute is applied to the value set titled 'Emergency Department Visit'. Condition/Diagnosis/Problem Diagnosis, Active Cardiac Arrest Intervention Intervention, Order Comfort Measures Intervention Intervention, Performed Comfort Measures American College of Emergency Physicians. All Rights Reserved. Quality Data Model (QDM), Version 4.1.2

22 Data Requirements Table Measure #2: Sepsis Management: Blood Cultures Ordered 22 Measure Component QDM* Category QDM* Datatype Value Set Name Standard Terminology OID Constraints Comments/Rationale Communication Communication: Patient to Provider Declined Care Condition/Diagnosis/Problem Diagnosis, Active Burn We seek public comment on the appropriate population of burn patients who should be excluded from this measure. Condition/Diagnosis/Problem Diagnosis, Active Seizure Condition/Diagnosis/Problem Diagnosis, Active Toxicological Emergency This value set includes the concept of metformin toxicity. We seek public comment on what other toxicological emergencies are relevant to these measures and should be included in this value set. Exclusions Condition/Diagnosis/Problem Diagnosis, Active Gastrointestinal Bleeding Condition/Diagnosis/Problem Diagnosis, Active Stroke Condition/Diagnosis/Problem Diagnosis, Active Myocardial Infarction Condition/Diagnosis/Problem Diagnosis, Active Acute Trauma Attribute Attribute: Ordinality Principal n/a This attribute determines that a diagnosis was the principal diagnosis for the 'Emergency Department Visit' and is applied to the value sets titled 'Gastrointestinal Bleeding', 'Stroke', 'Myocardial Infarction', and 'Acute Trauma'. Numerator Laboratory Test Laboratory Test, Order Blood Culture LOINC during [Occurrence A of Encounter, Performed: Exceptions There are no valid denominator exceptions 2015 American College of Emergency Physicians. All Rights Reserved. Quality Data Model (QDM), Version 4.1.2

23 23 MEASURE #3: Sepsis Management: Antibiotics Ordered Measure Description Percentage of emergency department visits for patients aged 18 years and older with septic shock who had an order for antibiotics during the emergency department visit Measure Components Numerator Statement Statement Exclusions Emergency department visits for patients who had an order for antibiotics during the emergency department visit All emergency department visits for patients aged 18 years and older with septic shock For purposes of this measure, patients with septic shock will be identified with any of the following criteria: Diagnosis of septic shock Diagnosis of sepsis and hypotension Diagnosis of infection and hypotension Patients with any of the following: Transferred into the emergency department from another acute care facility or other in-patient hospital setting Left before treatment was complete Died during the emergency department visit Cardiac arrest within the emergency department visit Patient or surrogate decision maker declined care Advanced directives present in patient medical record for comfort care Toxicological emergencies Burn Seizures Primary diagnosis of: o Gastrointestinal bleeding o Stroke o Acute myocardial infarction o Acute trauma Exceptions Rationale for the Measure Supporting Guideline None The emergency physician should order antibiotics for patients with septic shock in order to ameliorate patient decline. Delay in delivery of antibiotics in the emergency department puts the patient at high-risk for adverse outcomes such as drug reactions, increase length of hospital stay, and mortality. The following evidence statements are quoted verbatim from the referenced clinical guidelines and other references:

24 24 Surviving Sepsis Campaign: International Guidelines for Management of Severe Sepsis and Septic Shock 2012 The administration of effective intravenous antimicrobials within the first hour of recognition of septic shock (grade 1B) and severe sepsis without septic shock (grade 1C) should be the goal of therapy. Initial empiric anti-infective therapy of one or more drugs that have activity against all likely pathogens and that penetrate in adequate concentrations into tissues presumed to be the source of sepsis (grade 1B). We recommend that empiric antimicrobials be administered within 1 hour of the identification of severe sepsis. Blood cultures should be obtained before administering antibiotics when possible, but this should not delay initiation of antibiotics. The empiric drug choice should be changed as epidemic and endemic ecologies dictate (eg, H1N1, methicillin- resistant S. aureus, chloroquine-resistant malaria, penicillin-resistant pneumococci, recent ICU stay, neutropenia) (grade 1D). We recommend early and aggressive infection source control (grade 1D). We suggest the use of clindamycin and antitoxin therapies for toxic shock syndromes with refractory hypotension (grade 2D). C. difficile colitis should be treated with enteral antibiotics if tolerated. Oral vancomycin is preferred for severe disease (grade 1A). 1 Measure Importance Relationship to Desired Outcome Multiple studies demonstrate reduced mortality and improved outcomes for septic shock patients receiving timely antibiotics in the emergency department. 8,9 In addition, a delay in administration of antibiotics is associated with higher mortality, higher cost, and increased length of in-patient hospital stay. 10 Kumar et al found a 7.6% increase in mortality for every hour hypotensive patients with septic shock experienced a delay of receiving antimicrobials in the Intensive Care Unit. 11 Opportunity for Improvement Clinically, an increase in the duration of hypotension and elevated lactate in the absence of antibiotics in septic shock patients with gram-positive and gram-negative bacteremias has a demonstrated association with poor outcomes and death). 2 There is a mortality benefit with the delivery of anti-infective therapeutic drugs that combat activity against all likely pathogens and presumed sources of septic shock. 2 Results from a multicenter observational study including 15,022 patients from 165 hospitals demonstrated that patients with septic shock were given broad spectrum antibiotics 60.4% in the first quarter of the study. At the final quarter, the increase of compliance on providing antibiotics only increased 7.5% to 67.9%. Clearly, the opportunity to provide comprehensive and timely care to septic shock patients exists. 5 A multi-center randomized controlled trial of early sepsis resuscitation found mortality was significantly increased in patients who received initial antibiotics after septic shock recognition compared with before septic shock recognition. Only 59% of patients received

25 25 Related Measures the initial dose of antibiotics after recognition of septic shock. This demonstrates that delay to antibiotics is harmful and persists. 12 Staff has considered harmonization with CMS Hospital Inpatient Quality Reporting (IQR): Sepsis Bundle and NQF #0500: Severe Sepsis and Septic Shock Management Bundle Measure Designation Type of measure National Quality Strategy Priority/CMS Measure Domain (check all that apply) Level of Measurement (check all that apply) Additional Data Elements Process Outcome Structure Clinical Process-Effectiveness Patient Safety Patient Experience Care Coordination Efficiency: Overuse Efficiency: Cost Population & Community Health Individual clinicians Clinician groups Hospital Outpatient/ED Additional data elements for collection in the American College of Emergency Physician s Clinical Emergency Data Registry (CEDR) are described here. These data elements include: Diagnosis of severe sepsis Diagnosis of organ dysfunction Triage start date and time Provider contact date and time Treatment space date and time Disposition order from ED date and time ICU admission date and time OR admission date and time Antibiotic administration in ED start date and time

26 Data Requirements Table Measure #3: Sepsis Management: Antibiotics Ordered 26 Measure Component QDM* Category QDM* Datatype Value Set Name Standard Terminology OID Constraints Comments/Rationale Supplemental Data Elements Individual Characteristic Patient Characteristic ONC Administrative Sex Administrative Sex (HL7 v2.5) during measurement period Individual Characteristic Patient Characteristic Race CDC during measurement period Individual Characteristic Patient Characteristic Ethnicity CDC during measurement period Individual Characteristic Patient Characteristic Payer Source of Payment Typology during measurement period This data element is collected for the purpose of stratifying results in an effort to highlight disparities. This data element is collected for the purpose of stratifying results in an effort to highlight disparities. This data element is collected for the purpose of stratifying results in an effort to highlight disparities. This data element is collected for the purpose of stratifying results in an effort to highlight disparities. Measure Timing n/a Measurement Period n/a n/a by Measure Implementer Initial Population Individual Characteristic Patient Characteristic Age Calculation n/a Measurement start date minus Birth Date must be greater than or equal to > = 18 years AT Measurement Period 18 years For the purposes of this measure, 'Emergency Department Visit' is defined Encounter Encounter, Performed Emergency Department Visit, Occurrence A CPT during Measurement Period as the arrival time through the departure time according to EDBA consensus definitions (Wiler et al. 2015) Condition/Diagnosis/Problem Diagnosis, Active Infection Condition/Diagnosis/Problem Diagnosis, Active Acute Hypotension Condition/Diagnosis/Problem Diagnosis, Active Sepsis Condition/Diagnosis/Problem Diagnosis, Active Septic Shock Equals Initial Population Transfer of Care Transfer From Inpatient Facility starts before end of [Occurrence A of Encounter, Transfer of Care Transfer From Acute Care Facility starts before end of [Occurrence A of Encounter, Encounter Encounter, Performed Emergency Department Visit, Occurrence A CPT during Measurement Period For the purposes of this measure, 'Emergency Department Visit' is defined as the arrival time through the departure time according to EDBA consensus definitions (Wiler et al. 2015). This attribute is applied to the value set titled 'Emergency Department Visit'. This value set includes the concepts related to 'left against medical advice' and 'left before treatment completion', either with or without an intervention. Exclusions Attribute Attribute: discharge status Left Before Treatment Completion n/a Patient left before treatment completion (LBTC) - Patient left before being seen (LBBS) - Patient left before being seen without intervention (LBBS NI) - Patient left before being seen with intervention (LBBS WI) - Patient left subsequent to being seen (LSBS) (Wiler et al. 2015) Attribute Attribute: discharge status Patient Expired n/a This attribute is applied to the value set titled 'Emergency Department Visit'. Condition/Diagnosis/Problem Diagnosis, Active Cardiac Arrest Intervention Intervention, Order Comfort Measures Intervention Intervention, Performed Comfort Measures American College of Emergency Physicians. All Rights Reserved. Quality Data Model (QDM), Version 4.1.2

27 Data Requirements Table Measure #3: Sepsis Management: Antibiotics Ordered 27 Measure Component QDM* Category QDM* Datatype Value Set Name Standard Terminology OID Constraints Comments/Rationale Communication Communication: Patient to Provider Declined Care Condition/Diagnosis/Problem Diagnosis, Active Burn We seek public comment on the appropriate population of burn patients who should be excluded from this measure. Condition/Diagnosis/Problem Diagnosis, Active Seizure Condition/Diagnosis/Problem Diagnosis, Active Toxicological Emergency This value set includes the concept of metformin toxicity. We seek public comment on what other toxicological emergencies are relevant to these measures and should be included in this value set. Exclusions Condition/Diagnosis/Problem Diagnosis, Active Gastrointestinal Bleeding Condition/Diagnosis/Problem Diagnosis, Active Stroke Condition/Diagnosis/Problem Diagnosis, Active Myocardial Infarction Condition/Diagnosis/Problem Diagnosis, Active Acute Trauma Attribute Attribute: Ordinality Principal n/a This attribute determines that a diagnosis was the principal diagnosis for the 'Emergency Department Visit' and is applied to the value sets titled 'Gastrointestinal Bleeding', 'Stroke', 'Myocardial Infarction', and 'Acute Trauma'. Numerator Medication Medication, Order IV Antibiotics for Sepsis RxNorm during [Occurrence A of Encounter, Performed: Exceptions There are no valid denominator exceptions 2015 American College of Emergency Physicians. All Rights Reserved. Quality Data Model (QDM), Version 4.1.2