1. Clinical Document Architecture for Reporting Healthcare-Associated Infection Data Marla Albitz NHSN Project Manager Lockheed Martin Division of Healthcare Quality Promotion and National Center for Preparedness, Detection and Control of Infectious Diseases September 10, 2008 Atlanta, Georgia

2. Acknowledgements Surveillance Branch/Informatics Staff Venu SarraffMonica Shepard Jonathan Edwards Teresa Horan Maggie Dudeck Dan Pollock Dawn SievertWenkai Li Mary Andrus Carlasha Jenkins Kelly PetersonBobby Ray Ben Kupronis Consultants Alschuler Associates Frazier Consulting Association of Professionals in Infection Control SAIC Development Staff David McClanahan Romaine Tenney NCPHI Sundak Ganesan John Vrtachnik GB Kesarinath Vendors Theradoc, ICPA Medmined Premier Inc. Epiquest Vecna

3. Objectives Overview of the National Healthcare Safety Network (NHSN) The what, why and how of Clinical Document Architecture (CDA) for NHSN and Healthcare Associated Infection (HAI) Reporting Challenges and Lessons Learned

4. Web-based system that combines facility-level clinical performance measurement with national-level public health surveillance http://www.cdc.gov/ncidod/dhqp/nhsn_members.html Participating healthcare facilities use the NHSN application to enter, analyze, and share data CDC uses data collected through NHSN for aggregate analysis and reporting

5. NHSN’s technical design enables data entry via secure web pages or file transfers (standard electronic messages or documents) via secure internet connections.

6. Over 1700 healthcare facilities enrolled; many more expected to join Facilities in 47 states currently enrolled. Collaborations with Center for Medicare and Medicaid Services, Veterans Health Administration, and other federal agencies Collaborations with vendors of infection control surveillance systems.

7. Bloodstream Infection Surgical Site Infection Urinary Tract Infection Pneumonia Multi-drug Resistant Organism Influenza vaccination coverage Central Line Insertion Practices Non-protocol events such as Skin and Soft Tissue Infection Associated denominators NHSN Data Collection Forms

8. Surgical Site Infection Form

9. What is CDA? Paper XML* Fever Yes * Extensible Markup Language

10. What is XML? XML stands for EXtensible Markup Language XML is a markup language much like HTML XML was designed to carry data, not to display data XML tags are not predefined. You must define your own tags XML is designed to be self-descriptive XML is a W3C Recommendation

11. NHSN Web Interface and CDA Healthcare FacilityCDC CDC Firewall NHSN Database Entry of location mapping codes and monthly reporting plan Vendor system used to collect HAI data and create CDA document Facility Firewall Parsing and Validating CDA Document NHSN Application Web-based data entry and access

12. Standardize the structure and content of clinical documents for electronic exchange between systems or stand alone use Achieve semantic interoperability, i.e., the ability of two systems to share data, with no prior negotiations Provide a structured document foundation for standards-based electronic health record systems Objectives of CDA

13. CDA documents are encoded in Extensible Markup Language (XML) CDA documents derive their meaning from the HL7 v3 Reference Information Model (RIM ) and use HL7 v3 Data Types and vocabulary A CDA document consists of a header and a body Header is consistent across all clinical documents - identifies and classifies the document, provides information on patient, provider, encounter, and authentication Body contains narrative text / structured content Technical features

14. 1) Persistence - Documents exist over time and can be used in many contexts 2) Stewardship - Documents must be managed, shared by the steward 3) Potential for authentication - Intended use as a legal documentation 4) Wholeness - Document includes its relevant context 5) Human readability - Essential for human authentication CDA Characteristics

15. CDA Implementation Guides The Continuity of Care Document (CCD ) is an approved HL7 standard. Operative Notes (under development) Patient history and physical examination (under development) HAI Reporting (under development, first for public health) Morbidity reporting from healthcare to state and local health departments (awarded)

16. What is Electronic messaging? An HL7 message is a dataset that serves a particular communication purpose and is expressed consistent syntax with standard vocabulary. Messages are used to exchange data in real- time. They convey status information and provide “current” data. Microbiology results, ADT, Pharmacy data from already established mission critical systems in healthcare.

17. Electronic Messaging vs. CDA MessagesDocuments LifetimeTemporaryPersistent CommunicationTrigger basedHuman initiated SourceDesigned per system use case Defined by clinical precedent ContextMust be defined in each segment Document as a whole

18. Collaborators for HAI CDA Development NHSN Subject Matter Experts Implementation Guide consultants Vocabulary Specialists HL7 Structured Documents Work Group Infection Control Surveillance System Vendors

19. Components of CDA workflow 1) Implementation Guide – provides guidance to implementers of CDA. 2) Validator – xsl file that validates that a given CDA is well formed in accordance to the CDA R2 standard. 3) Schematron – validates the conformance to the Implementation Guidance. 4) Source application that generates the CDA document 5) Parsing tool that receives the CDA document – validates that the data received within the CDA document adheres to the data validation of the receiving application.

20. What is a clinical statement? Provides a standard way of expressing a discrete item of clinical information that is recorded because of its relevance to the care of a patient. The end result is that clinical observations such as a “fever” observation can be communicated consistently whenever it is expressed. Why is the clinical statement approach important in the context of data exchange?

21. Clinical Statement Types Observation (e.g. lab result) Procedure (e.g. Knee replacement) SubstanceAdministration (e.g. administer a medication) Supply (e.g. dispensing a drug) Encounter (e.g. hospitalization) Organizer (e.g. pairing of a pathogen and susceptibility test) Consent (e.g. consent for the information contained in the document to be released to a third party)

22. Implementation Guide: Conformance statements The Implementation Guide further constrains the RIM and specific direction to the implementer through conformance statements.

23. Conformance statements are used to create clinical statements in XML <value xsi:type="CD" codeSystem="2.16.840.1.113883.6.96" codeSystemName="SNOMED" code="386661006" displayName=“Fever"/>

24. Example of NHSN Clinical Criteria for Bloodstream Infection

25. Fever Yes <value xsi:type="CD" codeSystem="2.16.840.1.113883.6.96" codeSystemName="SNOMED" code=" 386661006 " displayName=“Fever"/> Required narrative block Structured Body

26. Fever Yes Required narrative block

27. <value xsi:type="CD" codeSystem="2.16.840.1.113883.6.96" codeSystemName="SNOMED" code="386661006" displayName=“Fever"/> Structured Body

28. codeSystemName="SNOMED" code="386661006" displayName=“Fever"/> Coded Value within the structured body

29. Standard Vocabulary in NHSN’s CDA Surgical Site Infection Report Signs & Symptoms □ Purulent drainage or material □ Pain or tenderness □ Localized swelling □ Redness □ Heat □ Fever □ Incision deliberately opened by surgeon SourceCode SNOMED307491001 NSHN termSS_pain NSHN termSS_locSwell SNOMED386713009 SNOMED304214002 SNOMED386661006 NSHN termSS_incision

30. NHSN/CDA status Bloodstream Infection pilot Fall 2007 Surgical Site Infection pilot Summer 2008 Implementation Guides currently under ballot for MDRO and clinical criteria. Implementation Guides currently under construction for Patient Flu and Central Line Insertion Practices events. Coming soon – Custom Events, UTI and PNEU

31. Lessons learned NHSN data requirements gathering - required work on a detailed data level that in some instances called for clarification from Subject Matter Experts and close collaboration with CDA modelers. Identified the value of working with vendors in terms of close reviews of the IG and reality checks in the form of pilot projects while the IG remains a work in progress Identified the value of working with Alschuler Associates (technical expertise with CDA and know- how with respect to HL7 processes) Identified the value of considering receiving data electronically and through a user interface when designing business rules.

32. Q & A Marla Albitz NHSN Project Manager Lockheed Martin contractor Centers for Disease Control and Prevention 1600 Clifton Road, NE Mail Stop A24 Atlanta, GA 30333 Office (404) 639-4292 e-mail: malbitz@cdc.gov Contact Information