How To Analyze Data From A Patient Record
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1 EHR Minimum Data Set Mark Roche, MD, MSMI Senior Health IT Advisor to the Office of the National Coordinator (ONC) 1
2 Agenda Current state DE Analysis background DE Analysis results Next Steps 2
3 Current state Multiple standards required (C-CDA, v2.5.1., QRDA, NCPDP SCRIPT etc.). Semantic Interoperability is ultimate goal but issues persist. Data entered once may not be used for multiple purposes (e.g. transition of care, immunization reports, billing, setc) 3
4 Goal Analyze Data Elements across existing standards HL7 v2, C- CDA, QRDA and NCPDP DEs for common MU data set Source: from MU2 and Interoperability Roadmap DEs for patient matching Timeline: 3 weeks FTE 4
5 Deliverable Systematic and detailed DE and vocabulary analysis across standards. Executive Summary Recommendations 5
6 Challenges Limited time! Horizontal breadth and vertical depth for each DE across spectrum of standards. Core standards come in different Versions and Implementation Guides (IG); some IGs are referenced in MU rule. Implementation Guides are written in different styles and formats! The language used to describe DE components is often different (different ways of naming data types, optionality, etc). 6
7 Analyzed Data Elements (DEs) Common MU Data Set 7 Patient name Sex Date of birth Race Ethnicity Preferred language Smoking status Problems Medications Medication allergies Laboratory test(s) Laboratory value(s)/result(s) Vital signs Care plan field(s), including goals and instructions Procedures Care team members Immunizations Unique device identifier(s) for a patient s implantable device(s) Notes/narrative Patient Matching First/Given Name Current Last/Family Name Previous Last/Family Name Middle/Second Given Name (includes middle initial) Suffix Date of Birth Current Address (street address, city, state, ZIP code) Historical Address (street address, city, state, ZIP code) Current Phone Number (if more than one is present in the patient record, all should be sent) Historical Phone Number Gender Definitions: DEs are singular or composite: Singular: Date of Birth (one field only) Composite: Problems (multiple fields: Problem Code, Problem Start Date, Problem Status, Problem Severity.)
8 What is Data Element? Various definitions: ISO , academics, DB field, data entry field etc. Recommendation: Always use examples! Critical DE characteristic Intended Purpose/Use: clinical, administrative, billing, research etc. MU Example: Problems Standard Data Elements C-CDA Patient Summary HL7 v2.5.1 LRI FHIR NCPDP SCRIPT Problem code (value) Diagnosis Code Condition.code Diagnosis Code Diagnosis Code Qualifier Diagnosis Code Count Effective time (high/low) Diagnosis Date/Time Condition.dateAsserted, Condition.onsetDateTime, Condition.onsetAge, Condition.abatementDate, Condition.abatementAge, Condition.abatementBoolean Problem Status Problem Severity Many more DEs Many more DEs 8
9 9
10 Approach - spectrum Present Future HL7 v2 NCPDP SCRIPT HL7 v3 Emerging Standards MU 1 MU 2 MU 3 10
11 Approach - analysis components Data Element Optionality & Cardinality Data Type, Format and Precision Vocabulary Code Systems, Values Sets, Value Set codes Vocabulary Binding Strength Analysis of Value Set codes Other characteristics as needed, 11
12 Overall statistics 12 Implementation Guides, versions and associated packages considered ~6,000 pages of documentation Some IGs have ~1,000 pages, some ~200 pages. Some IGs are broken into several documents ~150 distinct # of DEs across all IGs reviewed ~1,000 lookups ~60 Code Systems (~10) and Value Sets (~50) reviewed. Value sets analyzed to the individual code level where applicable and time-permitting. Value set details documented. 12
13 Analysis Resources Standards Compared HL7 v2, HL7 v3, NCPDP , FHIR List of Implementation Guides included in analysis HL7 v2.5.1 LRI R1.0 and R2.0 (full) HL7 v2.5.1 LOI from EHR (Dec 2013) (where applicable) HL7 v2.5.1 Immunizations v1.4 and v1.5 (where applicable) C-CDA R1.1(full) C-CDA R2.0 (full) QRDA Cat I R2 (full) QRDA Cat III R1(full) NCPDP (full) FHIR core (time-permitting) FHIR DAF Profile (time-permitting) 13
14 Part II: Executive Summary Observations and Recommendations 14
15 Observations 1 Discrepancies in Data Element optionality HL7 v2.5.1 LRI R2.0: (Patient Name) Suffix is Required but can be empty. HL7 v Immunizations v1.5: (Patient Name) Suffix is Optional. 15
16 Observation 2 Discrepancies in Data Element vocabulary: (Patient) Language Communication C-CDA R1.1: IETF, RFC 4646 C-CDA R2.0: ISO FHIR: IETF, RFC
17 Observation 3 Loose Data Element vocabulary binding strength Procedure Code SHOULD be LOINC or SNOMED CT MAY be CPT-4, ICD10PCS, CDT-2 17
18 Observations 4 Implementation Guides are updated. (a) Tightening DE requirement (reducing optionality): Medication dosequantity (e.g. 25mg). C-CDA R1.1: Medication information SHOULD have dosequantity C-CDA R2.0: Medication information SHALL have dosequantity 18
19 Observations 4 cont. (b) Tightening or changing vocabularies: Procedure code C-CDA R1.1: For body-altering Procedures (e.g. Appendectomy): SHOULD be LOINC or SNOMED CT MAY be CPT-4, ICD9 Procedures, ICD10 Procedures For Observational Procedures (e.g. Colonoscopy): SHOULD be LOINC or SNOMED CT MAY be CPT-4, ICD10 Procedures For all other procedures (e.g. wound care): SHOULD be LOINC or SNOMED CT C-CDA R2.0: SHOULD be LOINC or SNOMED CT MAY be CPT-4, ICD10PCS, CDT-2 The rule applies to all 3 procedure types consistently 19
20 Observations 5 Insufficient guidance on the use of nullflavor and nullflavor values, when required data element is unknown: NI (No information), NA (Not applicable), UNK (Unknown), ASKU (Asked, but not known). NASK (Not asked) etc. (Note: some standards do not have nullflavors ). nullflavors produced by on CCDA or QRDA may not be easily interpreted by other standards. For example, in v2.5.1 if data field is blank, it s interpreted as Unknown 20
21 Example Analysis Summary (next slides) 21
22 Patient Name - Overview V LRI R2.0 V Imm. v1.5 C-CDA/Q-RDA (all versions) NCPDP SCRIPT Notes Optionality Patient Name (general) R RE SHALL M Given (First Name)* RE R SHALL M Second and Further Given Names* RE RE SHALL (see Notes) O Family Name* RE R SHALL M Suffix* RE O MAY O Not a separate field (use Name Mother's Maiden Name O (separate data field) O (separate data field) Qualifier="Birth"?) -- C-CDA: If second or other names are not available, users should indicate "Not applicable" (NA). Instruction is vague though. Field Format/ Vocabulary Given (First Name)* Free Text Free Text Free Text Free Text Second and Further Given Names* Free Text Free Text Free Text Free Text Family Name* Free Text Free Text Free Text Free Text Suffix* Free Text Free Text Free Text Free Text Mother's Maiden Name Free Text Free Text Not a separate field (use Name Qualifier="Birth"?) -- Patient Name (general) Effective Date (O) Expiration Date (O) Effective Date (O) Expiration Date (O) Current vs. Historical* Schema permits validtime No mention on how to element, but IG doesn't mention distinguish previous vs this. current address Legend: XAD=Extended Address Data type, RE=Required but can be empty, R=required, O=Optional, M=Mandatory, SHALL=required, SHOULD=it would be super duper nice to provide the info, BS=Value Set Binding Strength Author: Mark Roche, MD 22
23 Unique Device Identifiers (UDIs) Optionality of UDI field: C-CDA and QRDA: required FHIR: optional HL7 v LRI (Lab results) and NCPDP SCRIPT do not contain fields for UDI. Format: C-CDA and QRDA have one data field for the full UDI string. Aside UDI, one other field can be used for the device name (e.g. pace-maker) FHIR accommodates significantly more UDI metadata(up to 11 fields) and allows UDI string components to be captured in distinct fields. (FHIR distinct data fields for UDI): - use (official, usual, temp, scondary...etc) - label (Description of identifier) - system (namespace for identifier) - value (The value that is unique) - period (validity period of ID) - assigner (organization that issued the ID, such as FDA, GS1). Other information: - manufacturer - model - version - manufacturedate - expiry - lotnumber - owner - location - patient - contact - url 23
24 Key Recommendations Within MU rule Review and align data element optionality, vocabulary and vocabulary binding strength across IGs and to the extent business/clinical use case allows. Across MU rules Provide clear transcoding/mapping guidance for versioned standards or rules to ensure that historical data is available. Provide clear requirements, instruction and interpretation of nullflavor or empty fields. Tighten optionality of critical DEs across all IGs (especially important for Patient Matching DEs). 24
25 Key Goals and Next Steps Key Goal: Ensure that data needs to be entered once into EHR and can be reused for multiple purposes (e.g. Transition of care, immunization reports, lab results reporting, billing..etc) Next Steps Create a library of Data Elements using ISO DE structure (Structured Data Capture initiative with S&I framework). Library available through a registry maintained by NCI, NLM, or other organizations. 25
26 Data Element library Source: 26
27 Data Element structure (ISO ) 27
28 Thank You! Q/A 28
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