Agenda

1. Agenda • For PSS preparation discuss naming of the final deliverables: – 3 Documents from OO • EHR Functional Profile for Lab • EHR Functional Requirements Implementation Guide for Lab Results Interface (LRI) • EHR Functional Requirements Implementation Guide for Lab Orders Interface (LOI) – 1 related Documents from CGIT • Conformance framework for Incorporate • Introduction to the main requirements table for LRI Transaction FR Specification • Background • Table

2. Laboratory Results Interface (LRI) Functional and Behavioral Requirements Implementation Guide S&I Framework, NIST, HL7 CGIT and OO WGs January 22nd, 2014 Revised 02/12/14, 03/10/14 – Draft 2.3 ST Updated 4/22/14 Contacts: robert.snelick@nist.govand rdieterle@earthlink.net

3. Functional Requirements Categories • Incorporation (focus of this slide deck) • Display (e.g., CLIA requirements) • Error Handling • Receiver unable to handle data volume • How to respond • Aggregate Requirements (Candidate requirements to consider) • What is a Lab Results • What is a Lab Report • What is a Patient Record • Matching (on what elements?) • General handling of the data (e.g., which DOB belongs to lab results) • ???? • Usability??? • Other “uses” of the data (display requirements is one use)

4. Problem Statement: MU-2 Criterion • Patient Safety • Common expectations for handling Lab Results • Consistent implementations for handling Lab Results • Regulatory Requirements • CLIA – general requirements (need more specificity) • Lack of Specificity of MU Requirements • Transmit Laboratory Results OK • LRI IG provides detailed requirements • Used by LIS (and EHRs with LIS module) for sending lab result messages to ambulatory EHR technology • Receive Laboratory Results OK • LRI IG provides detailed requirements • Used by ambulatory EHR technology for receiving lab result messages from LIS (or EHRs with LIS module) • Incorporate Laboratory Results NOT OK • LRI IG provides no guidance (not that it should, it is an interface specification) • MU-2 Criterion: “Incorporate Lab Results” – What does that mean? • Needed by ambulatory EHR technology for determining what to do with the data elements in the lab result messages received from LIS (or EHRs with LIS module)

5. Incorporate Lab Results – What does it mean? High-Level • HL7 GCIT, EHR, & OO WG • NIST • S&I Framework Lab Functional Profile Conformance Framework (Applicable to other domains) EHR Functional Model Lab Results Interface (LRI) IG Transaction Functional Requirements Requirements Community SMEs Very Specific HL7, S&I Framework, and NIST collaborate to produce the conformance framework Community subject matter experts determine the laboratory result-specific requirements The combination of the conformance framework and requirements = Functional and Behavioral Requirements (defining capabilities, such as Incorporate Lab Results)

6. Incorporate Lab Results Order A B 2 1 Lab Results Store Associate Use Patient Record Incorporate Link/combine specific data elements received in LRI message Lab Results Associate Provider • Incorporating lab results involves Storing data elements that were received in the LRI message (elements in scope) • Stored data elements are associated (linked) with a patient record • Stored data elements may be combined (linked) together in the EHR system to provide capabilities such as • Clinical Decision Support • A Public Health Report sent by an EHR system • A Laboratory Results Report display

7. Incorporate and Use Laboratory Results The Incorporate and Use Laboratory Results functional requirements specify how laboratory results data are to be • Imported, attributed, associated, or stored such that the data is subsequently available for use and • Used such that the laboratory results support various clinical purposes Definitions from the Edition 2014 certification criterion published by the Office of the National Coordinator for Health Information Technology (ONC) are provided below as examples • “‘Incorporate’ is used to mean to electronically import, attribute, associate, or link information in EHR technology.” • “…to electronically process structured information from another source such that it is combined (in structured form) with information maintained by EHR technology and is subsequently available for use within the EHR technology by a user.”

8. What Constitutes a Lab Results and Patient Record? • Lab Results • Exactly what is it? What data? • What parts are immutable and have to maintained/retrievable as such? • What is associated? • What parts are OK to be “just” part of the patient record? • Patient Record • Exactly what is it? What data? • Define aggregate requirements • Not addressed in this presentation • Coded elements triplets • Lab test report • Etc.

9. Incorporate Lab Results – NIST Approach for Edition 2014 Certification Testing HL7v2.5.1 Base Standard • HL7 v2.5.1 LRI IG was derived from Base Standard • NIST used LRI IG and consulted Laboratory SMEs • NIST developed LRI Test Tool, including Juror Document for ATLs* to use for lab results Incorporation Verification during certification testing • Test procedure not well defined—no requirements and very limited time • Testing only can be as good as the requirements they are based on • “incorporate” far to vague and not the responsibility of NIST to determine NIST consultation with Laboratory SMEs HL7v2.5.1 LRI IG LRI Juror Document used in NIST Validation Tool *Accredited Testing Laboratory

10. Incorporate Lab Results – NIST Juror Document for Edition 2014 Certification Testing Data Element Incorporation Categorization

11. Incorporate Lab Results – Preferred Approach for Edition 201X Certification Testing (Stage 3 MU) HL7v2.5.1 Base Standard • HL7 v2.5.1 LRI IG is derived from Base Standard • EHR-S FM Incorporate Lab Results Profile is derived from EHR-S FM • LRI Functional and Behavioral Requirements IG is derived from LRI IG and EHR-S FM Profile EHR-S FM Profile with LRI Details Incorporate and Use Conformance Framework EHR-S FM with High-level Requirements for “Incorporate” HL7v2.5.1 LRI IG Specific Functional & Behavioral Requirements Specific Message Elements LRI Transaction Functional Requirements IG Input to Testing

12. Incorporation and Use Process Diagram Sender Receiver Process Received Message per LRI IG Specifications Create and Send Message per LRI IG Specifications HL7 Lab Results Message In-scope Data Elements Incorporate Data Elements per LRI Functional & Behavioral Requirements IG Input Data, Create and Send Message Elements with R, RE, or C Usage 2 4 5 4 5 1 3 2 1 3 Parse and Process Use Data Elements per LRI Functional & Behavioral Requirements IG Store and Associate Use (Display, PH, CDA, CDS, etc.)

13. LRI Implementation Guide Scope LRI IG defines a very specific scope… …implies system functions… In-scope (Lab Results Incorporate) …says little about overall system capabilities System We are targeting requirements only within this scope

14. General Process The words “translate”, “translated”, and “translation” may be used differently by different HL7 Workgroups Defined Requirements Assigned Requirements IG / Standards Use Incorporate Location Usage Display (CDS/PHA) Store exact Exact Exact PID.3.1 ID# R Incorporate Use Name Type Code Permitted Permitted PID.5.7 RE Store exact • Exact • Stored equivalent • Referenced • Translated version of exact stored • Permitted • Store exact • Store exact; translation allowed & store translation • Translate & store OR store exact Or both • Made Available • Process Translate & store translation Ordering Provider ID# Stored equivalent Stored equivalent OBR.16.1 RE Store exact; translate & store translation Exact Exact R OBX.3.1 Obs ID Stored equivalent Stored equivalent Translate & store translation Text OBX.3.2 RE Each data element is assigned a requirement selected from the options defined for Incorporate or Display Exact Exact Store exact Obs Value OBX.5 RE Permitted Permitted Indifferent ObsMethod OBX.17 O Permitted Permitted Process Msg Profile ID MSH.21 RE Made Available Permitted Permitted PID.3.5 ID Type Code R

15. Store Requirements Store Store Action Options Implementation Choices If S-EX option is the requirement, then implementation SHALL “store” exactly and SHALL NOT “translate” Option assigned to each data element is the minimum requirement Store exactly S-TR S-EX Yes Store exactly; translation allowed, and if translated store translation If S-EX-TR option is the requirement, then implementation SHALL “store” exactly and MAY “translate” and if translated SHALL store translation S-EX-TR If S-TR option is the requirement, then the implementation SHALL implement one of the following: 1) “store” exactly, or 2) “translate” and SHALL store translation, or 3) 1 and 2 Translate and store translation OR store exactly OR both Provide to the system as needed to be used for logical operation; permitted to store exactly, translate and store translation or both If S-MA is the requirement, then S-EX, S-EX-TR, or S-TR also would be allowed S-MA Permitted Use in logical operation of system; permitted to discard, to store exactly, to translate and store translation, or both If S-PR is the requirement, then S-EX, S-EX-TR, S-TR, or S-MA also would be allowed S-PR

16. Providing Finer Granularity for Translate Store Translation Options Store Action Options Option assigned to each data element is the minimum requirement Store exactly S-EX S-TR OO-S-EQ Translate received data to equivalent value and then store OO-S-MEMap received data to local value via mapping table external to EHR, then store local value. In addition, store either a pointer to the referenced value in mapping table or store the original unmapped value OO-S-MIMap received data to value in internal table/file in EHR, then store pointer to referenced value Yes Store exactly; translation allowed, and if translated store translation S-EX-TR Translate can be further refined Translate and store translation OR store exactly OR both Provide to the system as needed to be used for logical operation; permitted to store exactly, translate and store translation or both S-MA Permitted Use in logical operation of system; permitted to discard, to store exactly, to translate and store translation, or both S-PR

17. Assigning Incorporation Requirement – OBX.3.1 Store Action Options Available to IG Authors Impact on Implementers Data Element S-EX Store data exactly as received, no translation stored S-EX-TRStore data exactly as received; translation allowed, and if translated store translation S-TR Translate data received and store translation OR store data exactly as received OR both EHR must be designed to store only exact data received in the message EHR must be designed to store exact data received in the messages, and also may be designed to translate the data and store the translated version EHR may be designed to translate data received and store translated version OR may be designed to store exact data received OR may be designed to do both OBX.3.1 Test ID IG Authors Choose Data Stored in EHR Data “30341-2” must be stored, no translation may be stored 30341-2 S-EX Store data exactly as received, no translation stored OR “30341-2” must be stored; may also be translated to “815117” and then translation also must be stored S-EX-TRStore data exactly as received; translation allowed, and if translated store translation OR S-TR Translate data received and store translation OR store data exactly as received OR both “30341-2” is translated to “815117” and translation must be stored OR “30341-2” must be stored exactly as received OR “30341-2” is translated to “815117” and translation must be stored; and “30341-2” also must be stored as exact data

18. Steps in Assigning Incorporation of Received Lab Data in EHR Incorporation Requirements Data Elements Hans suggested indicating both Sender and Receiver Usage Example Message Data Store Action Location Usage PATID1234 S-EX PID.3.1 ID# R MR S-TR ID Type PID.3.5 R Jones S-EX PID.5.1.1 Surname R William S-EX 19610615 S-EX-TR R PID.5.2 Given Name 20110331140551-0800 S-EX R PID.7.1 DoB 20110331160428-0800 S-EX Obs Date/Time OBR.7.1 R Test Rpt Date/Time S-EX-TR 30341-2 OBR.22.1 R Erythrocyte sedimentation rate S-EX-TR Test ID OBX.3.1 R 10 S-EX Test Text OBX.3.2 R mm/h S-EX Obs Value OBX.5 RE millimeter per hour S-EX N S-EX UoM ID OBX.6.1 RE UoM Text OBX.6.2 C(RE\X) Century Hospital S-EX 2070 Test Park St. S-TR Abn Flag OBX.8 R Los Angeles S-EX Perf Org OBX.23.1 R CA S-EX Street OBX.24.1 RE 90067 S-EX City OBX.24.3 RE State OBX.24.4 RE Zip OBX.24.5 RE *See Notes page for legend

19. Assigning Incorporation Requirement – OBX.3.2 Store Action Options Available to IG Authors Impact on Implementers Data Element S-EX Store data exactly as received, no translation stored S-EX-TRStore data exactly as received; translation allowed, and if translated store translation S-TR Translate data received and store translation OR store data exactly as received OR both EHR must be designed to store only exact data received in the message EHR must be designed to store exact data received in the messages, and also may be designed to translate the data and store the translated version EHR may be designed to translate data received and store translated version OR may be designed to store exact data received OR may be designed to do both OBX.3.2 Test Text IG Authors Choose Data Stored in EHR Data “Erythrocyte sedimentation rate” must be stored, no translation may be stored Erythrocyte sedimentation rate S-EX Store data exactly as received, no translation stored OR “Erythrocyte sedimentation rate” must be stored; may also be translated to “Sed Rate” and then translation also must be stored S-EX-TRStore data exactly as received; translation allowed, and if translated store translation OR “Erythrocyte sedimentation rate” is translated to “Sed Rate” and translation must be stored S-TR Translate data received and store translation OR store data exactly as received OR both OR “Erythrocyte sedimentation rate” must be stored exactly as received OR “Erythrocyte sedimentation rate” is translated to “Sed Rate” and translation must be stored; and “Erythrocyte sedimentation rate” also must be stored as exact data

20. Steps in Assigning Incorporation of Received Lab Data in EHR Incorporation Requirements Data Elements Example Message Data Store Action Location Usage PATID1234 S-EX PID.3.1 ID# R MR S-TR ID Type PID.3.5 R Jones S-EX PID.5.1.1 Surname R William S-EX 19610615 S-EX-TR R PID.5.2 Given Name S-EX 20110331140551-0800 R PID.7.1 DoB 20110331160428-0800 S-EX Obs Date/Time OBR.7.1 R Test Rpt Date/Time S-EX-TR 30341-2 OBR.22.1 R Erythrocyte sedimentation rate S-EX-TR Test ID OBX.3.1 R 10 S-EX Test Text OBX.3.2 R mm/h S-EX Obs Value OBX.5 RE millimeter per hour S-EX N S-EX UoM ID OBX.6.1 RE UoM Text OBX.6.2 C(RE\X) Century Hospital S-EX 2070 Test Park St. S-TR Abn Flag OBX.8 R Los Angeles S-EX Perf Org OBX.23.1 R CA S-EX Street OBX.24.1 RE 90067 S-EX City OBX.24.3 RE State OBX.24.4 RE Zip OBX.24.5 RE *See Notes page for legend

21. Assigning Incorporation Requirement – OBX.5 Store Action Options Available to IG Authors Impact on Implementers Data Element S-EX Store data exactly as received, no translation stored S-EX-TRStore data exactly as received; translation allowed, and if translated store translation S-TR Translate data received and store translation OR store data exactly as received OR both EHR must be designed to store only exact data received in the message EHR must be designed to store exact data received in the messages, and also may be designed to translate the data and store the translated version EHR may be designed to translate data received and store translated version OR may be designed to store exact data received OR may be designed to do both OBX.5 Observation Value For OBX.5 the Store requirement is specific to the data type IG Authors Choose Data Stored in EHR Data “10” must be stored, no translation may be stored S-EX Store data exactly as received, no translation stored 10 (If Data type is NM) OR X X “10” must be stored; may also be translated to “nn” and then translation also must be stored S-EX-TRStore data exactly as received; translation allowed, and if translated store translation OR X X “10” is translated to “nn” and translation must be stored S-TR Translate data received and store translation OR store data exactly as received OR both OR X “10” must be stored exactly as received OR X “10” is translated to “nn” and translation must be stored; and “10” also must be stored as exact data

22. Steps in Assigning Incorporation of Received Lab Data in EHR Incorporation Requirements Data Elements Example Message Data Store Action Location Usage PATID1234 S-EX PID.3.1 ID# R MR S-TR ID Type PID.3.5 R Jones S-EX PID.5.1.1 Surname R William S-EX 19610615 S-EX-TR R PID.5.2 Given Name 20110331140551-0800 S-EX R PID.7.1 DoB 20110331160428-0800 S-EX Obs Date/Time OBR.7.1 R Test Rpt Date/Time S-EX-TR 30341-2 OBR.22.1 R Erythrocyte sedimentation rate S-EX-TR Test ID OBX.3.1 R 10 S-EX Test Text OBX.3.2 R mm/h S-EX Obs Value OBX.5 RE millimeter per hour S-EX N S-EX UoM ID OBX.6.1 RE UoM Text OBX.6.2 C(RE\X) Century Hospital S-EX 2070 Test Park St. S-TR Abn Flag OBX.8 R Los Angeles S-EX Perf Org OBX.23.1 R CA S-EX Street OBX.24.1 RE 90067 S-EX City OBX.24.3 RE State OBX.24.4 RE Zip OBX.24.5 RE *See Notes page for legend

23. Assigning Incorporation Requirement – OBX.24.1 Store Action Options Available to IG Authors Impact on Implementers Data Element S-EX Store data exactly as received, no translation stored S-EX-TRStore data exactly as received; translation allowed, and if translated store translation S-TR Translate data received and store translation OR store data exactly as received OR both EHR must be designed to store only exact data received in the message EHR must be designed to store exact data received in the messages, and also may be designed to translate the data and store the translated version EHR may be designed to translate data received and store translated version OR may be designed to store exact data received OR may be designed to do both OBX.24.1 PerfOrg Street Address IG Authors Choose Data Stored in EHR Data 2070 Test Park St. “2070 Test Park St.” must be stored, no translation may be stored S-EX Store data exactly as received, no translation stored OR “2070 Test Park St.” must be stored; may also be translated to “2070 Test Park Street” and then translation also must be stored S-EX-TRStore data exactly as received; translation allowed, and if translated store translation OR “2070 Test Park St.” is translated to “2070 Test Park Street” and translation must be stored S-TR Translate data received and store translation OR store data exactly as received OR both OR “2070 Test Park St.” must be stored exactly as received OR “2070 Test Park St.” is translated to “2070 Test Park Street” and translation must be stored; and “2070 Test Park St.” also must be stored as exact data

24. Steps in Assigning Incorporation of Received Lab Data in EHR Incorporation Requirements Data Elements Example Message Data Store Action Location Usage PATID1234 S-EX PID.3.1 ID# R MR S-TR ID Type PID.3.5 R Jones S-EX PID.5.1.1 Surname R William S-EX 19610615 S-EX-TR R PID.5.2 Given Name 20110331140551-0800 S-EX R PID.7.1 DoB 20110331160428-0800 S-EX Obs Date/Time OBR.7.1 R Test Rpt Date/Time S-EX-TR 30341-2 OBR.22.1 R Erythrocyte sedimentation rate S-EX-TR Test ID OBX.3.1 R 10 S-EX Test Text OBX.3.2 R mm/h S-EX Obs Value OBX.5 RE millimeter per hour S-EX N S-EX UoM ID OBX.6.1 RE UoM Text OBX.6.2 C(RE\X) Century Hospital S-EX 2070 Test Park St. S-TR Abn Flag OBX.8 R Los Angeles S-EX Perf Org OBX.23.1 R CA S-EX Street OBX.24.1 RE 90067 S-EX City OBX.24.3 RE State OBX.24.4 RE Zip OBX.24.5 RE *See Notes page for legend

25. Century Hospital Laboratory Report 2070 Test Park Street OBX.23.1 PID.5.2 PID.5.1.1 Los Angeles, CA 90067 PID.7.1 OBX.24.1 OBX.24.5 Jones, William (6/15/1961) Name/DoB: OBX.24.4 Patient ID: MR# PATID1234 PID.3.1 OBX.24.3 PID.3.5 Collection Date/Time: 3/31/2011 1405 ET OBR.7.1 Report Date/Time: 3/31/2011 1604 ET OBR.22.1 ESR (815117) 3/31/2011 1405 ET OBX.3.1 OBX.3.2 10 mm/h OBR.7.1 OBX.8 OBX.5 Location of abnormal flag if result value is not normal Displays in red text if result value is not normal

26. Steps in Incorporation of Received Lab Data and Display in EHR Incorporation Requirements Display Requirements Data Elements Example Message Data Store Action Laboratory Report Location Usage PATID1234 S-EX U-EX PID.3.1 ID# R MR S-TR U-EQ (MR#) ID Type PID.3.5 R Jones S-EX U-EX PID.5.1.1 Surname R William S-EX U-EX 19610615 S-EX-TR U-TR (6/15/1961) R PID.5.2 Given Name 20110331140551-0800 S-EX U-TR (3/31/2011 1406 ET) R PID.7.1 DoB 20110331160428-0800 S-EX U-TR (3/31/2011 1604 ET) Obs Date/Time OBR.7.1 R Test Rpt Date/Time S-EX-TR 30341-2 U-REF (815117) OBR.22.1 R Erythrocyte sedimentation rate S-EX-TR U-TR (ESR) Test ID OBX.3.1 R 10 S-EX U-EX Test Text OBX.3.2 R mm/h S-EX U-EX Obs Value OBX.5 RE Not Used millimeter per hour S-EX (ColorCode/flag Abnormals Only) N U-TR S-EX UoM ID OBX.6.1 RE UoM Text OBX.6.2 C(RE\X) Century Hospital S-EX U-EX 2070 Test Park St. S-TR U-EX Abn Flag OBX.8 R Los Angeles S-EX U-EX Perf Org OBX.23.1 R CA S-EX U-EX Street OBX.24.1 RE 90067 S-EX U-EX City OBX.24.3 RE State OBX.24.4 RE Zip OBX.24.5 RE *See Notes page for legend

27. Store Exact Version: S-EX EHR John Cohen Patient Record John Cohen Result 10 Result 10 • The “Store Exact Version: S-EX” diagram illustrates the incorporation requirement where data received in the message are stored unaltered in the EHR technology and related to the appropriate patient record • In this example, John Cohen is a patient whose laboratory result value (OBX.5) is “10” • When this laboratory result is received in the message, it is stored as is in the patient’s record in the EHR Message

28. Store Exact and Equivalent Version: S-EX-TR EHR John Cohen Patient Record Test Name Erythrocyte Sedimentation Rate John Cohen Test Name Erythrocyte Sedimentation Rate Test Name ESR • The “Store Exact and Equivalent Version: S-EX-TR” diagram illustrates the incorporation requirement where data received in the message are stored exactly and also translated to an equivalent value and then stored in the EHR technology related to the appropriate patient record • In this example, John Cohen is a patient for whom an Erythrocyte Sedimentation Rate laboratory test has been performed • When the laboratory result message is received, the test name is stored both as “Erythrocyte Sedimentation Rate” and as “ESR” (which is equivalent to Erythrocyte Sedimentation Rate) in the patient’s record Message

29. Translate and Store or Store Exactly or Both Version: S-TR/OO-S-MI EHR Physician ID Table B Dr. Dan Carter John Cohen Patient Record B Dr. Beth Smyth B Dr. … Dr. Dan Carter B Ordering Provider Name pointer • The “Translate and Store or Store Exactly or Both Version: S-TR/OO-S-MI” diagram illustrates the incorporation requirement where data received in the message are linked to data in an existing specific record or table in the EHR technology, so the value in that existing record or table is the “stored” version • Note: the data in the existing record or table must match the received data exactly • In this example, Dr. Dan Carter is a physician whose information exists within an internal Physician Identification Table in the EHR technology • When a message containing data about Dr. Carter as the Ordering Provider is received, they are stored in the patient’s record in the EHR using a pointer to the referenced values in the Physician Identification Table Message (OO-S-MI Map received data to value in internal table/file in EHR, then store pointer to referenced value)

30. Translate and Store or Store Exactly or Both Version: S-TR/OO-S-ME EHR John Cohen Patient Record Lab Result Mapping Table Local Code 68590 Lab Test Result LN Local LN 718-8 529-8 12340 718-8 68590 …. …. pointer OO-S-ME Map received data to local value via mapping table external to EHR, then store local value. In addition, store either a pointer to the referenced value in mapping table or store the original unmapped value Message

31. Requirement for Incorporation - Translate and Store or Store Exactly or Both Version (S-TR/OO-S-ME) • The “Translate and Store or Store Exactly or Both Version: S-TR-OO-S-ME” diagramillustrates the incorporation requirement where data received in the message are mapped to related “local” data (i.e. EHR internal data in the EHR technology) so the EHR local value, which is mapped to a record in an external table that contains the received value, is stored in the patient record • The received version of the data must be derivable for use via the mapping function, and the derived version of the data must match exactly the original data received in the message • In this example • A laboratory test with specific LOINC code is received in the message • The LOINC code is mapped to an EHR internal (Local) code in the EHR technology • The Local code -- along with a pointer to the LOINC code and version in the external table -- is stored in the patient record • When the LOINC code that was received in the message needs to be utilized, it is derived by the EHR technology via the pointer to the external LOINC table

32. Made Available Version: S-MA EHR John Cohen Patient Record John Cohen A 123 A 123 matched… & may be discarded Message

33. Requirements for Incorporation – Made Available Version (S-MA) • The “Made Available Version: S-MA” diagram illustrates the incorporation requirement where data received in the message are processed and made available for operational purposes (such as matching) as indicated by relevant functional requirements • Once the data are utilized for the operational purpose, they do not need to be stored, associated, or displayed, so they may be discarded • In this example • A patient identification number is received in the message • This number is used for matching in order to associate the lab results data to John Cohen’s patient record in the EHR technology • Once the exact match is made, the patient identification number data received in the message may be discarded

34. Use Options Store Use Options Derivation Action Options U-EX Use exact version of stored data; Clinical Decision Support Public Health Reporting U-TR Translate exact stored data to equivalent value Display in EHR Yes Other… U-REFUse referenced data based on stored pointer U-EQ Use stored equivalent value Other… Permitted Not Applicable NONE (for certification testing)

35. Requirements for Use - Display

36. Extra Slides

37. Steps in Determining Incorporation and Use of Received Data Incorporation of Data Use of Data Store Options Store Action Options Use Options S-EX None (Store data exactly as received only) Clinical Decision Support Yes S-EX-TR Store exactly; translation allowed, and if translated store translation Public Health Reporting Display in EHR Other… Permitted* S-TR Translate and store translation OR store exactly OR both Derivation Action Options Translation Options 1 U-EX Use exact version of stored data; maintain an audit trail that includes the value used Determine if data element is always to be stored, or if data element is a “Made Available” or “Process” kind of data element OO-S-EQ Translate received data to equivalent value and then store U-TR Translate exact stored data to equivalent value; maintain an audit trail that includes the value used OO-S-ME Map received data to local value via mapping table external to EHR, then store local value. In addition, store either a pointer to the referenced value in mapping table or store the original unmapped value U-REF Use referenced data based on stored pointer; maintain an audit trail that includes the value used OO-S-MI Map received data to value in internal table/file in EHR, then store pointer to referenced value U-EQ Use stored equivalent value; maintain an audit trail that includes the value used Certification Testing Options* Made Available (S-MA): Availability of the data is verified during certification testing; storage of these data is not verified during certification testing Other… Process (S-PR): Certification testing is indifferent for these data; storage of these data is not verified during certification testing *Options for data that usually are not incorporated, i.e., are either “Made Available” or “Process” kinds of data

38. Steps in Determining Incorporation and Use of Received Data Incorporation of Data Use of Data Store Options Store Action Options Use Options S-EX None (Store data exactly as received only) Clinical Decision Support Yes S-EX-TR Store exactly; translation allowed, and if translated store translation Public Health Reporting Display in EHR Other… Permitted* S-TR Translate and store translation OR store exactly OR both Derivation Action Options Translation Options U-EX Use exact version of stored data; maintain an audit trail that includes the value used 2 OO-S-EQ Translate received data to equivalent value and then store If data element is always to be stored, determine the action to be applied for storing U-TR Translate exact stored data to equivalent value; maintain an audit trail that includes the value used OO-S-ME Map received data to local value via mapping table external to EHR, then store local value. In addition, store either a pointer to the referenced value in mapping table or store the original unmapped value U-REF Use referenced data based on stored pointer; maintain an audit trail that includes the value used OO-S-MI Map received data to value in internal table/file in EHR, then store pointer to referenced value U-EQ Use stored equivalent value; maintain an audit trail that includes the value used Certification Testing Options* Made Available (S-MA): Availability of the data is verified during certification testing; storage of these data is not verified during certification testing Other… Process (S-PR): Certification testing is indifferent for these data; storage of these data is not verified during certification testing *Options for data that usually are not incorporated, i.e., are either “Made Available” or “Process” kinds of data

39. Steps in Determining Incorporation and Use of Received Data Incorporation of Data Use of Data Store Options Store Action Options Use Options S-EX None (Store data exactly as received only) Clinical Decision Support Yes S-EX-TR Store exactly; translation allowed, and if translated store translation Public Health Reporting Display in EHR Other… Permitted* S-TR Translate and store translation OR store exactly OR both Derivation Action Options Translation Options U-EX Use exact version of stored data; maintain an audit trail that includes the value used OO-S-EQ Translate received data to equivalent value and then store 3 U-TR Translate exact stored data to equivalent value; maintain an audit trail that includes the value used OO-S-ME Map received data to local value via mapping table external to EHR, then store local value. In addition, store either a pointer to the referenced value in mapping table or store the original unmapped value If data element is assigned a S-EX-TR or S-TR Store Action, determine the Translation Option to be applied U-REF Use referenced data based on stored pointer; maintain an audit trail that includes the value used OO-S-MI Map received data to value in internal table/file in EHR, then store pointer to referenced value U-EQ Use stored equivalent value; maintain an audit trail that includes the value used Certification Testing Options* Made Available (S-MA): Availability of the data is verified during certification testing; storage of these data is not verified during certification testing Other… Process (S-PR): Certification testing is indifferent for these data; storage of these data is not verified during certification testing *Options for data that usually are not incorporated, i.e., are either “Made Available” or “Process” kinds of data

40. Steps in Determining Incorporation and Use of Received Data Incorporation of Data Use of Data Store Options Store Action Options Use Options S-EX None (Store data exactly as received only) Clinical Decision Support Yes S-EX-TR Store exactly; translation allowed, and if translated store translation Public Health Reporting Display in EHR Other… Permitted* S-TR Translate and store translation OR store exactly OR both Derivation Action Options Translation Options U-EX Use exact version of stored data; maintain an audit trail that includes the value used 4 OO-S-EQ Translate received data to equivalent value and then store Determine use(s) for stored data U-TR Translate exact stored data to equivalent value; maintain an audit trail that includes the value used OO-S-ME Map received data to local value via mapping table external to EHR, then store local value. In addition, store either a pointer to the referenced value in mapping table or store the original unmapped value U-REF Use referenced data based on stored pointer; maintain an audit trail that includes the value used OO-S-MI Map received data to value in internal table/file in EHR, then store pointer to referenced value U-EQ Use stored equivalent value; maintain an audit trail that includes the value used Certification Testing Options* Made Available (S-MA): Availability of the data is verified during certification testing; storage of these data is not verified during certification testing Other… Process (S-PR): Certification testing is indifferent for these data; storage of these data is not verified during certification testing *Options for data that usually are not incorporated, i.e., are either “Made Available” or “Process” kinds of data

41. Steps in Determining Incorporation and Use of Received Data Incorporation of Data Use of Data Store Options Store Action Options Use Options S-EX None (Store data exactly as received only) Clinical Decision Support Yes S-EX-TR Store exactly; translation allowed, and if translated store translation Public Health Reporting Display in EHR Other… Permitted* S-TR Translate and store translation OR store exactly OR both Derivation Action Options Translation Options U-EX Use exact version of stored data; maintain an audit trail that includes the value used OO-S-EQ Translate received data to equivalent value and then store 5 U-TR Translate exact stored data to equivalent value; maintain an audit trail that includes the value used Determine the derivation action to be applied for use of the data OO-S-ME Map received data to local value via mapping table external to EHR, then store local value. In addition, store either a pointer to the referenced value in mapping table or store the original unmapped value U-REF Use referenced data based on stored pointer; maintain an audit trail that includes the value used OO-S-MI Map received data to value in internal table/file in EHR, then store pointer to referenced value U-EQ Use stored equivalent value; maintain an audit trail that includes the value used Certification Testing Options* Made Available (S-MA): Availability of the data is verified during certification testing; storage of these data is not verified during certification testing Other… Process (S-PR): Certification testing is indifferent for these data; storage of these data is not verified during certification testing *Options for data that usually are not incorporated, i.e., are either “Made Available” or “Process” kinds of data

42. Possible Receive / Store / Use Combinations Diagram Store(in Patient’s Record) Receive Use* U-EX 1. S-EX S-EX-TR S-EX S-TR S-EX-TR ABC ABC ABC U-TR 2. ABC abc ABC OO-S-MI EHR Table ABC U-EX ABC ABC 3. abc U-TR abc ABC 4. ABC U-REF U-REF ABC EHR Internal Table ABC …. Pointer Pointer ABC 5. OO-S-ME abc ABC EHR External Table ABC …. *For example, clinical decision support, public health reporting, display in EHR