Implementing GI Quality Measures: Where does the HL7 Clinical Document Architecture fit? June 09, Bob Dolin, MD

Transcription

1 Semantically Yours, LLC. All rights reserved. Implementing GI Quality Measures: Where does the HL7 Clinical Document Architecture fit? June 09, 2009 Bob Dolin, MD 1

2 About me Bob Dolin, MD, FACP, FACMI HL7 Chair-elect, HL7 Board of Directors Co-chair, HL7 Structured Documents WG Co-editor, HL7 Clinical Document Architecture Co-editor, Using SNOMED CT in HL7 Version 3 US HITSP Co-chair, HITSP Foundations Committee SNOMED Prior member, SNOMED International Editorial Board Member, IHTSDO Content Committee Responsible for Kaiser Permanente s enterprise-wide SNOMED CT deployment. Semantically Yours, LLC Healthcare interoperability standards consultant 2

3 Outline Evolving US quality reporting framework HL7 Clinical Document Architecture Clinical scenario HL7 Quality Reporting Document Architecture 3

4 US Interoperability Standards development HHS federal recognition ONC oversight AHIC/NeHC - prioritization HITSP align use cases with standards CCHIT - certification NHIN implementation IHE end to end profiling SDO standards development HL7 clinical messages and documents IHTSDO clinical terminology NCPDP - medications X12 - financial HITSP HHS ONC CCHIT AHIC NHIN NCPDP HL7 X12 IHE IHTSDO 4

5 US Interoperability Standards development HHS ONC HIT Policy Committee HIT Standards Committee NIST NHIN NCPDP HL7 IHTSDO X12 IHE 5

6 Quality framework and where CDA fits feedback ONC/HITSP Quality Use Case NCQA, AMA, APQ... Measure definition The Collaborative, RAND emeasure specification Measure Development emeasure Specification NQF HITEP Quality Data Set HIMSS IHE: Multi-party choreography using HL7 messages, services CDA (QRDA) CDA (QRDA) CDA (QRDA) Aggregators, Requestors

7 What is the CDA? The CDA is a document markup standard for the structure and semantics of an exchanged "clinical document". A clinical document is a documentation of observations and other services with the following characteristics: Persistence Stewardship Potential for authentication Context Wholeness Human readability A CDA document is a defined and complete information object that can exist outside of a message, and can include text, images, sounds, and other multimedia content. 7

8 CDA Business Case CDA hits the sweet spot CDA encompasses all of clinical documents. A single standard for the entire EHR is too broad. Multiple standards and/or messages for each EHR function may be difficult to implement. CDA is just right. Implementation experience - CDA has been an ANSI standard since 2000, and has been balloted through HL7's consensus process. CDA is widely implemented. Gentle on-ramp to information exchange - CDA is straight-forward to implement, and provides a mechanism for incremental semantic interoperability. Improved patient care - CDA provides a mechanism for inserting best practices and evidence-based medicine directly into the process of care (via the same template mechanism used to build CCD), thereby making it easier to do the right thing. Lower costs CDA s top down strategy let s you implement once, and reuse many times for new scenarios. 8

9 Key Aspects of the CDA CDA documents are encoded in Extensible Markup Language (XML). CDA is derived from HL7's central Reference Information Model (RIM), thereby enabling data reusability - with lab or pharmacy messages, with claims attachments, clinical trials, etc. The CDA specification is richly expressive and flexible. Templates, conformance profiles, and implementation guides can be used to constrain the generic CDA specification. (More on this when we talk about CCD ) 9

10 Major Components of a CDA Document <ClinicalDocument>... <structuredbody> <section> <text>...</text> <observation>...</observation> <substanceadministration> <supply>...</supply> </substanceadministration> <observation> <externalobservation>... </externalobservation> </observation> </section> <section> <section>...</section> </section> </structuredbody> </ClinicalDocument> External References Narrative Block E N T R I E S S E C T I O N S Header B O D Y D O C U M E N T 10

11 CDA Model CDA R2 object model, showing a portion of the header and its connection to the document body representedorganization Organization classcode*: <= ORG determinercode*: <= INSTANCE id: SET<II> [0..*] name: SET<ON> [0..*] telecom: SET<TEL> [0..*] addr: SET<AD> [0..*] standardindustryclasscode: CE CWE [0..1] <= OrganizationIndustryClass ClinicalDocument classcode*: <= DOCCLIN moodcode*: <= EVN id*: II [1..1] code: CE CWE [1..1] <= DocumentType title: ST [0..1] effectivetime: TS [1..1] confidentialitycode: CE CWE [1..1] <= x_basicconfidentialitykind languagecode: CS CNE [0..1] <= HumanLanguage 0..* parentdocument relateddocument typecode*: <= x_actrelationshipdocument ParentDocument classcode*: <= DOCCLIN moodcode*: <= EVN id*: SET<II> [1..*] code: CD CWE [0..1] <= DocumentType text: ED [0..1] setid: II [0..1] versionnumber: INT [0..1] AssignedEntity classcode*: <= ASSIGNED id: SET<II> [1..*] code: CE CWE [0..1] <= RoleCode addr: SET<AD> [0..*] telecom: SET<TEL> [0..*] 0..1 assignedperson Person classcode*: <= PSN determinercode*: <= INSTANCE name: SET<PN> [0..*] 1..* assignedentity author typecode*: <= AUT functioncode: CE CWE [0..1] <= ParticipationFunction contextcontrolcode*: CS CNE [1..1] <= "OP" time*: TS [1..1] 0..1 assignedentity legalauthenticator typecode*: <= LA contextcontrolcode*: CS CNE [1..1] <= "OP" time*: TS [1..1] signaturecode*: CS CNE [1..1] <= ParticipationSignature 1..1 bodychoice component typecode*: <= COMP contextconductionind*: BL [1..1] "true" bodychoice NonXMLBody classcode*: <= DOCBODY moodcode*: <= EVN text: ED [1..1] confidentialitycode: CE CWE [0..1] <= x_basicconfidentialitykind languagecode: CS CNE [0..1] <= HumanLanguage StructuredBody classcode*: <= DOCBODY moodcode*: <= EVN confidentialitycode: CE CWE [0..1] <= x_basicconfidentialitykind languagecode: CS CNE [0..1] <= HumanLanguage component typecode*: <= COMP contextconductionind*: BL [1..1] "true" 1..* section 1..* assignedauthor author Section classcode*: <= DOCSECT moodcode*: <= EVN id: II [0..1] code: CE CWE [0..1] <= DocumentSectionType title: ST [0..1] text*: ED [0..1] confidentialitycode: CE CWE [0..1] <= x_basicconfidentialitykind languagecode: CS CNE [0..1] <= HumanLanguage 11

12 CDA Model CDA R2 object model, showing the connection from a document section to nested CDA entries. Organization classcode*: <= ORG determinercode*: <= INSTANCE id: SET<II> [0..*] name: SET<ON> [0..*] telecom: SET<TEL> [0..*] addr: SET<AD> [0..*] standardindustryclasscode: CE CWE [0..1] <= OrganizationIndustryClass DrugOrOtherMaterial LabeledDrug classcode*: <= MMAT determinercode*: <= KIND code: CE CWE [0..1] <= DrugEntity name: EN [0..1] Material classcode*: <= MMAT determinercode*: <= KIND code: CE CWE [0..1] <= MaterialEntityClassType name: EN [0..1] lotnumbertext: ST [0..1] Section classcode*: <= DOCSECT moodcode*: <= EVN id: II [0..1] code: CE CWE [0..1] <= DocumentSectionType title: ST [0..1] text*: ED [0..1] confidentialitycode: CE CWE [0..1] <= x_basicconfidentialitykind languagecode: CS CNE [0..1] <= HumanLanguage 0..1 manufacturerorganization component typecode*: <= COMP contextconductionind*: BL [1..1] "true" 0..* section entryrelationship ManufacturedProduct classcode*: <= MANU id: SET<II> [0..*] 1..1 manufactureddrugorothermaterial typecode*: <= x_actrelationshipentryrelationship contextconductionind*: BL [1..1] "true" 0..1 subject entry typecode*: <= x_actrelationshipentry contextconductionind*: BL [1..1] "true" 0..* clinicalstatement 1..1 manufacturedproduct consumable typecode*: <= CSM 0..1 manufacturedproduct * product typecode*: <= PRD 0..* clinicalstatement clinicalstatement Observation classcode*: <= OBS moodcode*: <= x_actmooddocumentobservation id: SET<II> [0..*] code*: CD CWE [1..1] <= ObservationType negationind: BL [0..1] statuscode: CS CNE [0..1] <= ActStatus effectivetime: IVL<TS> [0..1] value: ANY [0..1] targetsitecode: SET<CD> CWE [0..*] SubstanceAdministration classcode*: <= SBADM moodcode*: <= x_documentsubstancemood id: SET<II> [0..*] code: CD CWE [0..1] <= SubstanceAdministrationActCode statuscode: CS CNE [0..1] <= ActStatus effectivetime: GTS [0..1] repeatnumber: IVL<INT> [0..1] routecode: CE CWE [0..1] <= RouteOfAdministration dosequantity: IVL<PQ> [0..1] Supply classcode*: <= SPLY moodcode*: <= x_documentsubstancemood id: SET<II> [0..*] code: CD CWE [0..1] <= ActCode statuscode: CS CNE [0..1] <= ActStatus effectivetime: GTS [0..1] quantity: PQ [0..1] Procedure classcode*: <= PROC moodcode*: <= x_documentproceduremood id: SET<II> [0..*] code: CD CWE [0..1] statuscode: CS CNE [0..1] <= ActStatus effectivetime: IVL<TS> [0..1] prioritycode: CE CWE [0..1] <= ActPriority methodcode: SET<CE> CWE [0..*] approachsitecode: SET<CD> CWE [0..*] targetsitecode: SET<CD> CWE [0..*] 0..* observationrange referencerange typecode*: <= REFV 0..* criterion precondition typecode*: <= PRCN ObservationRange classcode*: <= OBS moodcode*: <= EVN.CRT code: CD CWE [0..1] <= ActCode text: ED [0..1] value: ANY [0..1] interpretationcode: CE CNE [0..1] <= ObservationInterpretation Criterion classcode*: <= OBS moodcode*: <= EVN.CRT code: CD CWE [0..1] <= ActCode text: ED [0..1] value: ANY [0..1] 12

13 Temperature is 36.9 C. CDA Body Entries <section> <code code="8716-3" codesystem=" " codesystemname="loinc"/> <title>vital Signs</title> <text>temperature is 36.9 C</text> <entry> <observation classcode="obs" moodcode="evn"> <code code=" " codesystem=" " codesystemname="snomed CT" displayname="body temperature"/> <statuscode code="completed"/> <effectivetime value=" "/> <value xsi:type="pq" value="36.9" unit="cel"/> </observation> </entry> </section> Required narrative block Optional entries 13

14 CDA Body Entries Father had fatal heart attack in <section> <code code=" " codesystem=" " codesystemname="loinc"/> <title>family history</title> <text>father had fatal heart attack in 1970.</text> <entry> <observation classcode="obs" moodcode="evn"> <code code="assertion" codesystem=" "/> <value xsi:type= CD code=" " codesystem=" " codesystemname="snomed CT" displayname="mi"/> <effectivetime value="1970"/> <subject> <relatedsubject classcode="prs"> <code code="fth" codesystem= /> </relatedsubject> </subject> <entryrelationship typecode="caus"> <observation classcode="obs" moodcode="evn"> <code code="assertion" codesystem=" "/> <value xsi:type= CD code=" " codesystem=" " displayname="death"/> <effectivetime value="1970"/> </observation> </entryrelationship> </observation> </entry> 14

15 CDA Body Entries Suture removal from left forearm performed. <section> <code code=" " codesystem=" " codesystemname="loinc"/> <title>in-office Procedures</title> <text>suture removal from left forearm performed.</text> <entry> <procedure classcode="proc" moodcode="evn"> <code code=" " codesystem=" " codesystemname="snomed CT" displayname="suture removal"> <qualifier> <name code=" " codesystem=" " displayname="procedure site"/> <value code=" " codesystem=" " displayname="left forearm"/> </qualifier> </code> <effectivetime value=" "/> </procedure> </entry> </section> 15

16 CDA Body Entries Captopril 25mg PO every 12 hours <section> <code code=" " codesystem=" " codesystemname="loinc"/> <title>medications</title> <text>captopril 25mg PO every 12 hours.</text> <entry> <substanceadministration classcode="sbadm" moodcode="evn"> <effectivetime xsi:type="pivl_ts"> <period value="12" unit="h"/> </effectivetime> <routecode code="po" codesystem=" " codesystemname="routeofadministration"/> <dosequantity value="1"/> <consumable> <manufacturedproduct> <manufacturedlabeleddrug> <code code="317172" codesystem=" " codesystemname="rxnorm" displayname="captopril 25mg oral tablet"/> </manufacturedlabeleddrug> </manufacturedproduct> </consumable> </substanceadministration> </entry> </section> 16

17 The A in CDA CDA R2 consists of a single CDA XML Schema, and the architecture arises from the ability to apply one or more templates which serve to constrain the richness and flexibility of CDA. Professional society recommendations, national clinical practice guidelines, standardized data sets can be expressed as CDA templates. This presentation will describe the CDA template process, and will show how the ASTM Continuity of Care Record (CCR) data set is used as a template to constrain CDA specifically for summary documents, resulting in the HL7/ASTM Continuity of Care Document (CCD) specification. 17

18 The A in CDA There are many kinds of templates that might be created. Among them, two are particularly relevant for clinical documents: (1) those that constrain the document sections based on the type of document (section-level templates); (2) those that constrain the entries within document sections (entry-level templates). CDA Schema CDA Schema :: Progress Note section-level template applied. CDA Schema :: Progress Note section-level and Vital Signs entrylevel template applied. CDA Schema :: Endocrinology Progress Note section-level and Vital Signs entry-level template applied. CDA Schema :: Progress Note section-level and ICU Vital Signs entry-level template applied. CDA Schema :: Cardiology Progress Note section-level template applied CDA Schema :: Cardiology Progress Note section-level and Cardiac Exam entry-level template applied. CDA Schema :: Endocrinology Progress Note section-level template applied. CDA Schema :: Endocrinology Progress Note section-level and Vital18 Signs entry-level template applied.

19 CDA Templates a clinical scenario Evidence-based medicine often manifests through the creation of Clinical Practice Guidelines. Clinical Practice Guidelines are most useful when integrated into the process of care. Integration options include: Templates Alerts Clinical Practice Guidelines can be transformed into CDA templates, to guide the collection of key data elements. 19

20 A typical day in the office History Henry Levin, the 7th is a 67 year old male referred for further asthma management. Onset of asthma in his teens. He was hospitalized twice last year, and already twice this year. He has not been able to be weaned off steroids for the past several months. Past Medical History Asthma Hypertension Medications Theodur 200mg BID Proventil inhaler 2puffs QID PRN Prednisone 20mg qd HCTZ 25mg qd Allergies Penicillin - Hives Aspirin - Wheezing Social History Smoking :: 1 PPD between the ages of 20 and 55, and then he quit. cont... 20

21 A typical day in the office Physical Exam Vital Signs :: BP 196/100; Wt 185lb; Resp 16 and unlabored; T 98.6F; HR 86 and regular. Lungs :: Clear with no wheeze. Good air flow. Cardiac :: RRR with no murmur, no S3, no S4. Labs PFTs 02/03/1999: FEV1 1.2; FVC 1.9; FEV1/FVC = CBC 02/03/1999: Hgb 15.1; WBC 7.2; PLT 279k; MCV 88. ABG 02/03/1999: (room air) po2 78; pco2 48; ph CXR 02/03/1999: Hyperinflated. Normal cardiac silhouette, clear lungs. PFTs today: FEV1 1.4; FVC 2.0; FEV1/FVC = Peak Flow today: 260 l/m. Assessment Asthma, with prior smoking history. Difficulty weaning off steroids. Will try gradual taper. Hypertension, poorly controlled. Add lopressor. Plan Complete PFTs with lung volumes. Chem-7 Provide educational material on inhaler usage and peak flow self-monitoring. Decrease prednisone to 20qOD alternating with 18qOD. Lopressor 25mg BID. RTC 1 week.

22 A typical day in the office Lab Order Form CBC with Differential Count Chem-7 Liver Enzymes Calcium Magnesium Urinalysis Theophylline level X Cardiopulmonary Order Form Test: Complete Pulmonary Function Study with Lung Volumes Arterial Blood Gas Treadmill Stress Test, Routing Echocardiogram Other (Specify) :: X Indications: Baseline evaluation Specific Questions:

23 A typical day in the office Health Summary Form Screening DATE DATE DATE DATE DATE DATE Colonoscopy Breast Exam Mammogram Pap Smear PSA Immunizations DATE DATE DATE DATE DATE DATE Pneumovax Influenza Education DATE DATE DATE DATE DATE DATE Cholesterol Smoking Seat Belts 23

24 Am I following the NHLBI guidelines? Which environmental and occupational triggers did I ask about? I forgot to ask about triggers. Have I provided proper patient education? Information to answer this question is in the narrative portion of my note. Is my assessment of asthma severity consistent with the NHLBI guidelines? NHLBI asthma severity is based on several factors, the worst of which determines diagnosis.

25 NHLBI Asthma Template The NHLBI Asthma Guidelines can be expressed as a CDA template. A CDA document that is authored with the NHLBI Asthma Template will conform to the CDA standard AND will conform to the additional constraints in the template. 25

26 NHLBI Asthma Template History Frequency of wheezing: Daily and continual. Daily but not continual. Episodes per week :: Labs Peak Flow :: l/m. Assessment Asthma, Intermittent. Asthma, Mild Persistent. Asthma, Moderate Persistent. Asthma, Severe Persistent. Plan Pneumococcal Vaccine Complete PFTs with lung volumes. Provide education on peak flow self-monitoring. Environmental and Occupational screening questionnaire. Teach inhaler/spacer/holding chamber technique. Discuss environmental control measures to avoid exposure to known allergens and irritants. Teach self-monitoring.

27 NHLBI Asthma Template Plan Pneumococcal Vaccine Complete X PFTs with lung volumes. Provide X education on peak flow self-monitoring. Environmental and <section> Occupational screening questionnaire. Teach inhaler/spacer/holding <templateid chamber root=" /> technique. Discuss environmental <title>plan</title> control measures to avoid exposure to known allergens and irritants. Teach self-monitoring. <text>complete PFTs with lung volumes; Provide education on peak flow self-monitoring;...</text> <entry> <observation classcode="obs" moodcode="int"> <code code=" " codesystem= &SNOMEDCT;" displayname="pulmonary function test"/> </observation> </entry> <entry> <act classcode="act" moodcode="int"> <code code=" " codesystem= &SNOMEDCT;" displayname="teaching of skills"> <qualifier> <name code=" " displayname="has focus"/> <value code=" " displayname="peak flow rate measurement"/> </qualifier> </code>

28 NHLBI Asthma Template NHLBI Guideline defines the Template. HL7 RIM defines the fields. Standard terminologies define the field values. And it s all packaged together in a standardized way within the CDA.

29 NHLBI Asthma Template atop CDA NHLBI Guideline defines the Template. HL7 RIM defines the fields. Standard terminologies define the field values. <section> <templateid root=" "/> <title>plan</title> <text>complete PFTs with lung volumes; Provide education on peak flow self-monitoring;...</text> <entry> <observation classcode="obs" moodcode="int"> <code code=" " codesystem= &SNOMEDCT;" displayname="pulmonary function test"/> </observation> </entry> <entry> <act classcode="act" moodcode="int"> <code code=" " codesystem= &SNOMEDCT;" displayname="teaching of skills"> <qualifier> <name code=" " displayname="has focus"/> <value code=" " displayname="peak flow rate measurement"/> </qualifier> </code> And it s all packaged into CDA.

30 NHLBI Asthma Template atop CDA NHLBI Guideline defines the Template. HL7 RIM defines the fields. Standard terminologies define the field values. And it s all packaged into CDA. <section> <templateid root=" "/> <title>plan</title> <text>complete PFTs with lung volumes; Provide education on peak flow self-monitoring;...</text> <entry> <observation classcode="obs" moodcode="int"> <code code=" " codesystem= &SNOMEDCT;" displayname="pulmonary function test"/> </observation> </entry> <entry> <act classcode="act" moodcode="int"> <code code=" " codesystem= &SNOMEDCT;" displayname="teaching of skills"> <qualifier> <name code=" " displayname="has focus"/> <value code=" " displayname="peak flow rate measurement"/> </qualifier> </code>

31 NHLBI Asthma Template atop CDA Which environmental and occupational triggers did I ask about? Have I provided proper patient education? Plan Pneumococcal <section> Vaccine X Complete PFTs <templateid with lung volumes. root=" "/> X Provide education <title>plan</title> on peak flow self-monitoring. Environmental and <text>complete Occupational screening PFTs questionnaire. with lung volumes; Provide education Teach inhaler/spacer/holding on peak chamber flow self-monitoring; technique....</text> Discuss environmental <entry> control measures to avoid exposure to known allergens and irritants. Teach self-monitoring. <observation classcode="obs" moodcode="int"> <code code=" " codesystem= &SNOMEDCT;" displayname="pulmonary function test"/> </observation> </entry> <entry> <act classcode="act" moodcode="int"> <code code=" " codesystem= &SNOMEDCT;" displayname="teaching of skills"> <qualifier> <name code=" " displayname="has focus"/> <value code=" " displayname="peak flow rate measurement"/>

32 Is my assessment of asthma severity c/w NHLBI? Severe Persistent NHLBI Asthma Template atop CDA Symptoms (cough, wheeze, shortness of breath, chest tightness) Continual symptoms Daily limited physical activity Maintenance oral corticosteroids More than 1 steroid burst the past month History Frequency of wheezing: Daily X and continual. Daily but not continual. Labs Peak Flow :: 260 l/m. Nighttime Symptoms Frequent (at least 4 nights per week) Lung Function FEV 1 or PEF 60% predicted PEF variability >30% (AM/PM) Assessment Asthma, Intermittent. Asthma, Mild Persistent. Asthma, X Moderate Persistent. Asthma, Severe Persistent. 32

33 Quality Reporting Document Architecture Project Goal To standardize the framework of quality reports and to define the way quality measurement data should be structured to create interoperability between reporting and receiving systems.

34 Types of QRDA Reports Category 1: Single Patient Reports DSTU ballot Category 2: Patient List Reports Informative ballot, for comments Category 3: Calculated Reports Informative ballot, for comments 34

35 Layout of a QRDA Cat I Report 35

36 Sample QRDA Category 1 Report Contains raw patient data No assertion about the status of quality compliance When pooled and analyzed, each report contributes to quality compliance

37 Vermont-Oxford Neonatal Admission Temperature

38 CHCA BMI Index Percentile Measure

39 Sample QRDA Category 2 Report Proposed as a multipatient level report Includes flags for each patient indicating whether the patient qualifies for the numerator, denominator, exclusion

40 Sample QRDA Category 3 Report Aggregate quality report Calculated summary data for one or more measures on a population

41 HL7 web site: For more information HL7 Structured Documents listserver (public but must register to post): CDA: Dolin RH, Alschuler L, Boyer S, Beebe C, Behlen FM, Biron PV, Shabo A. HL7 Clinical Document Architecture, Release 2. J Am Med Inform Assoc. 2006;13: ( CDA R2 Quality Reporting Document Architecture, Draft Standard for Trial Use 41