Report on eMeasure, Quality Reporting Document Architecture, and Neonatal Care Report Compatibility March 2010 Contents Introduction ..................................................................................................... 3 Purpose ......................................................................................................... 3 Background ................................................................................................... 3 Clinical Document Architecture (CDA) ........................................................ 3 Neonatal Care Report (NCR) ....................................................................... 4 Health Quality Measures Format (HQMF) ................................................... 4 Quality Reporting Document Architecture (QRDA)...................................... 5 Comparative Effectiveness Research (CER) ................................................. 5 Coordinated Standards for Reporting, Reuse, Research and Improvement ........ 6 Template Reuse and Measure Creation.......................................................... 6 Relationships among NCR, QRDA, and eMeasure .......................................... 6 Conclusion ....................................................................................................... 9 References ...................................................................................................... 10 Figures Figure 1: Flow Diagram .................................................................................... 7 Report on eMeasure, Quality Reporting Document Architecture, and Neonatal Care Report Compatibility 2 Introduction The Children’s Hospitals Neonatal Consortium (CHNC) is a group of 27 children’s hospital Neonatal Intensive Care Units (NICUs) committed to evaluating the effectiveness of tertiary neonatal intensive care in their unique patient population. Since 2006, CHNC has developed a consensus set of data elements related to outcomes of critically ill infants requiring highly specialized care. CHNC selected The Health Level Seven (HL7) Clinical Document Architecture (CDA) Release 2 standard to represent a subset of this data for reporting. Using this subset the Child Health Corporation of America (CHCA) and Alschuler Associates, LLC created the Neonatal Care Report (NCR) Implementation Guide for CDA Release 2 that passed HL7 ballot in January 2010. The Child Health Work Group and Structured Documents Work Group (SDWG) provided support to that effort. Infants referred from delivery centers to children’s hospital NICUs often include rare and complex disorders requiring pediatric subspecialty care. Historically, there has been a profound lack of knowledge regarding best practices in this population. With the NCR, CHNC aims to systematically collect and analyze uniform clinical data on infants admitted to children’s hospital NICUs, and CHNC expects to spearhead benchmarking, quality improvement, and research initiatives not previously possible in their patient population. Purpose This white paper explores the relationship among two HL7 CDA standard conformance profiles—the Neonatal Care Report (NCR) and the Quality Reporting Document Architecture (QRDA)—and a complementary HL7 standard called eMeasure (HQMF). The paper describes how these standards operate in concert to support end-to-end information capture, reuse, analysis, and improvement that can spearhead new benchmarking, quality improvement, and research initiatives in the this patient population. Background Clinical Document Architecture (CDA) CDA Release 2 is a document markup standard that specifies the structure and semantics of clinical documents for the purpose of electronic health information exchange. The standards-based approach to reporting simplifies technical implementation by using a widely implemented data standard and reduces the burden of reporting among participants through reuse of electronic health record (EHR) data supported by common models, terminology and templates. Use of common data definitions and reporting processes based on national Report on eMeasure, Quality Reporting Document Architecture, and Neonatal Care Report Compatibility 3 standards reduces the need for providers to reformat data for submission to multiple recipients. The approach offers a national collaborative and consensus-based process that includes vendor involvement. CDA use is expected to increase significantly in the next five years now that the U.S. Office of the National Coordinator for Health Information Technology (ONC) has adopted it as a required standard to support meaningful use of certified EHR technology. Neonatal Care Report (NCR) The Neonatal Care Report Implementation Guide (IG) Draft Standard specifies a standard for electronic submission of NCRs in a CDA Release 2 format. The CHNC core data set contains around 700 data elements; the NCR draft standard addresses a subset of approximately 60 data elements, including 37 physiologic and laboratory elements for assessment of illness severity and 21 base data elements (e.g., name, medical record number, birth weight, Apgar scores, admission weight, birth and discharge head circumference). The data elements selected for the subset had a previously existing similar template or had a high probability of reuse. The initial data subset provided the opportunity to work with the data from the perspective of the underlying model and electronic format and to explore many design issues thoroughly. Some of the data elements included in the NCR correspond to the Vermont Oxford Network (VON); others correspond to data collection sets mapped to national standards such as the HL7 Continuity of Care Document (CCD). This NCR Implementation Guide supports reusability and ease of data collection through a standard data representation balloted through Health Level Seven (HL7) Health Quality Measures Format (HQMF) The Health Quality Measures Format (HQMF) is a standard for representing a health-quality measure as an electronic document. A quality measure is a quantitative tool that measures an action, process, or outcome of clinical care to provide an indication of an individual’s or organization’s performance in relation to a specified process or outcome. Through standardization of a measure's structure, metadata, definitions, and logic, the HQMF provides for consistency and unambiguous interpretation of quality measures. A health-quality measure encoded in the HQMF format is referred to as an "eMeasure". Standardization of document structure (e.g., sections), metadata (e.g., author, verifier), and definitions (e.g., "numerator", "initial patient population") achieves a minimal level of consistency and readability across a wide range of measures, currently existing in a variety of formats, even if not fully machine processable. Report on eMeasure, Quality Reporting Document Architecture, and Neonatal Care Report Compatibility 4 From there, formal representation of the clinical, financial, and/or administrative concepts and logic within an eMeasure supports unambiguous interpretation and consistent reporting.1 ONC has recommended eMeasure as a national standard to support meaningful use of certified EHR technology. Quality Reporting Document Architecture (QRDA) Quality Reporting Document Architecture (QRDA) is an XML document format that defines constraints on CDA Release 2 Header and Body elements for quality reporting. It provides a standard structure with which to report endorsed quality measure data to organizations that will analyze and interpret the data.2 ONCHIT is considering QRDA as a national standard to support meaningful use of certified EHR technology. Comparative Effectiveness Research (CER) The Institute of Medicine (IOM) defines Comparative Effectiveness Research (CER) (CER) as: CER is the generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat, and monitor a clinical condition or to improve the delivery of care. The purpose of CER is to assist consumers, clinicians, purchasers, and policy makers to make informed decisions that will improve health care at both the individual and population levels.3 “One important aspect of comparative effectiveness research is that it should be conducted in ‘real world’ settings, with a full range of patients, not just those selected for clinical trials, and involve the typical resources available to physicians and patients,” said Joe Selby, MD, MPH, director of the KaiserPermanente Division of Research, which has pioneered much of the comparative-effectiveness research and has improved patient care based on that research. “An important asset for conducting this research is the large clinical databases generated from the delivery of real world care and captured in electronic health records.”4 The CHNC database is just such a database. HL7 Version 3 Standard: Representation of the Health Quality Measures Format (eMeasure), Release 1 – September 2009 Ballot 2 Implementation Guide For CDA Release 2 - Quality Reporting Document Architecture (QRDA) 3 REPORT BRIEF • JUNE 2009 Initial National Priorities for Comparative Effectiveness Research 4 Health care policy leaders discuss “comparative effectiveness” research, University of California San Francisco News Office, January 29, 2010 1 Report on eMeasure, Quality Reporting Document Architecture, and Neonatal Care Report Compatibility 5 Coordinated Standards for Reporting, Reuse, Research and Improvement Template Reuse and Measure Creation The NCR, QRDA, and eMeasure all contain or specify data about interventions or results that are associated with patient outcomes. The NCR contains data compiled throughout an infant’s neonatal ICU encounter and thought to be related to outcomes of sick infants. The HQMF eMeasure defines quality measures for consistency and unambiguous interpretation. The QRDA reports data from EHRs about a specific quality measure or group of measures to organizations that measure quality. NCR data-element definitions can be reused within neonatal quality measures. Vetted measures can inform future iterations of NCR to establish template reuse between the NCR and QRDA. New eMeasures can ensure capture of the correct data elements from the EHRs. This approach provides these potential win-win situations: Providers can reuse data structured for NCR when they report on quality measures using QRDA. Researchers can use the collected NCR-compliant data to develop new measures. The care of neonates can be assessed and improved nationwide. Relationships among NCR, QRDA, and eMeasure The flow diagram that follows illustrates relationships among NCR, QRDA, and eMeasure core components. Report on eMeasure, Quality Reporting Document Architecture, and Neonatal Care Report Compatibility 6 Figure 1: Flow Diagram Data collection, research, measure development CHCA Hospital EHR A NCR CDA 2 CHNC Database 1 1 2 CHCA Hospital EHR B NCR CDA 3 CHNC Templates Database 7 Measure reporting, performance improvement 7 Comparative effectiveness research 4 Create QRDAs Submit evidence-based measures to endorsing organization (NQF) 6 7 6 8 Hospital EHR C 7 5 9 Measure Quality 6 Create meaningful quality eMeasures to query EHRs 6 Hospital EHR D 10 Encourage evidencebased interventions 11 Neonatal care/ outcomes improve nationwide 1. The CHNC template database stores and indexes data element templates for reuse by CHNC hospitals. Hospitals use the templates to drive data collection and reporting. 2. CHNC hospitals use NCR CDAs to send data from disparate systems to the CHNC database in a standard format. 3. With the received data, CHNC performs CER. 4. Data collected in the CHNC database and CER drives development of new measures. 5. CHNC submits data-supported evidence-based measures to endorsing organizations. Measure developers and eMeasure technical groups work together to develop meaningful quality eMeasures. 6. CHCA hospitals-- potentially all hospitals nationwide with similar patient populations -- use these eMeasures to query their EHRs. 7. Hospitals create QRDAs using existing NCR templates and new or previously developed neonatal QRDA templates. 8. Hospitals send QRDAs to Quality organizations or other processing entities. 9. Quality organizations or other processing entities process and analyze the data from the QRDAs. Report on eMeasure, Quality Reporting Document Architecture, and Neonatal Care Report Compatibility 7 10. Quality organizations and governing bodies encourage evidence-based interventions nationwide. 11. Neonatal care and outcomes improve nationwide. Report on eMeasure, Quality Reporting Document Architecture, and Neonatal Care Report Compatibility 8 Conclusion The standardized quality process provided by NCR, QRDA, and eMeasure has the potential to augment knowledge and standardize the care of sick neonates nationwide. Any CDA document, including QRDA, can reuse the NCR templates. The NCR can transmit data from disparate systems using templates for data elements that provide useful information about infants with rare disorders as well as those who comprise the majority of the neonatal intensivecare population. Thus, the three specifications described here work together in an end-to-end process for quality data collection, research, and improvement. This process will increase knowledge regarding best practices and promote evidence-based interventions, quality outcomes, and efficient care for all sick neonates. Report on eMeasure, Quality Reporting Document Architecture, and Neonatal Care Report Compatibility 9 References 1. HL7 Version 3 Standard: Representation of the Health Quality Measures Format (eMeasure), Release 1 – September 2009 Ballot. 2. HL7 Implementation Guide for CDA Release 2 Quality Reporting Document Architecture (QRDA) Draft Standard for Trial Use March 2009. Available at: http://www.hl7.org/documentcenter/ballots/2008sep/downloads/CDA R2_QRDA_R1_DSTU_2009APR.zip 3. Dolin RH, Alschuler L, Boyer S, Beebe C, Behlen FM, Biron PV, Shabo A, (Editors). HL7 Clinical Document Architecture, Release 2.0. ANSIapproved HL7 Standard; May 2005. Ann Arbor, Mich.: Health Level Seven, Inc. Available through HL7 or if an HL7 member with the following link: http://www.hl7.org/documentcenter/private/standards/cda/r2/cda_r2 _normativewebedition.zip 4. HL7 Implementation Guide for CDA Release 2 Neonatal Care Report (NCR) Draft Standard for Trial use – January 2010 Balloted package available at http://www.hl7.org/documentcenter/ballots/2010JAN/downloads/CDA R2L3_IG_NEONATALRPT_R1_D1_2010JAN.zip 5. Health care policy leaders discuss “comparative effectiveness” research, University of California San Francisco News Office, January 29, 2010. 6. IOM definition for Comparative Effectiveness Research, available at javascript:HandleLink('cpe_29033_0','CPNEWWIN:NewWindow%5etop=10 ,left=10,width=500,height=400,toolbar=1,location=1,directories=0,status =1,menubar=1,scrollbars=1,resizable=1@CP___PAGEID=29038,/Policy/L egislationTakeAction/upload/CER-report-brief-6-22-09.pdf Report on eMeasure, Quality Reporting Document Architecture, and Neonatal Care Report Compatibility 10