1. 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 22 nd, 2014 Revised 02/12/14, 03/10/14 – Draft 2.3 ST Updated 4/22/14 Contacts: robert.snelick@nist.gov and rdieterle@earthlink.net

3. 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. 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. 5 Incorporate Lab Results – What does it mean? 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)  HL7 GCIT, EHR, & OO WG  NIST  S&I Framework Requirements Community SMEs Transaction Functional Requirements Conformance Framework EHR Functional Model Lab Functional Profile High-Level Very Specific (Applicable to other domains) Lab Results Interface (LRI) IG

6. 6 Incorporate Lab Results 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 Store Associate Use Patient Record Lab Results Associate Link/combine specific data elements received in LRI message Incorporate Lab Results Order Provider A B 2 1

7. 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. 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. 9 Incorporate Lab Results – NIST Approach for Edition 2014 Certification Testing 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 HL7v2.5.1 Base Standard HL7v2.5.1 LRI IG LRI Juror Document used in NIST Validation Tool NIST consultation with Laboratory SMEs *Accredited Testing Laboratory 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

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

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

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

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

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

15. 15 S-MAS-PR Option assigned to each data element is the minimum requirement Store Yes Permitted Store Action Options S-EX Store Requirements S-EX- TR S-TR If S-EX option is the requirement, then implementation SHALL “store” exactly and SHALL NOT “translate” If S-MA is the requirement, then S-EX, S-EX-TR, or S-TR also would be allowed If S-EX-TR option is the requirement, then implementation SHALL “store” exactly and MAY “translate” and if translated SHALL store translation If S-PR is the requirement, then S-EX, S-EX-TR, S-TR, or S-MA also would be allowed Implementation Choices 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 Store exactly Store exactly; translation allowed, and if translated store translation 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 Use in logical operation of system; permitted to discard, to store exactly, to translate and store translation, or both

16. 16 S-MAS-PR Option assigned to each data element is the minimum requirement Store Yes Permitted Store Action Options S-EX Providing Finer Granularity for Translate S-EX- TR S-TR Store exactly Store exactly; translation allowed, and if translated store translation 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 OO-S-EQ Translate received data to equivalent value and then store 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 OO-S-MI Map received data to value in internal table/file in EHR, then store pointer to referenced value Translation Options Use in logical operation of system; permitted to discard, to store exactly, to translate and store translation, or both Translate can be further refined

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

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

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

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

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

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

23. 23 Assigning Incorporation Requirement – OBX.24.1 OBX.24.1 Perf Org Street Address Data Element Store Action Options Available to IG Authors S-EX Store data exactly as received, no translation stored S-EX-TR Store 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 Impact on Implementers 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 2070 Test Park St. S-EX Store data exactly as received, no translation stored IG Authors ChooseData Stored in EHR Data S-TR Translate data received and store translation OR store data exactly as received OR both S-EX-TR Store data exactly as received; translation allowed, and if translated store translation “2070 Test Park St.” must be stored, no translation may be stored “2070 Test Park St.” must be stored; may also be translated to “2070 Test Park Street” and then translation also must be stored “2070 Test Park St.” is translated to “2070 Test Park Street” and translation must be stored OR “2070 Test Park St.” must be stored exactly as received “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 OR

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

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

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

27. 27 EHR Message Result 10 John Cohen John Cohen Patient Record Result 10 Store Exact Version: S-EX 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

28. 28 EHR Message Test Name Erythrocyte Sedimentation Rate John Cohen John Cohen Patient Record Store Exact and Equivalent Version: S-EX-TR 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 Test Name ESR Test Name Erythrocyte Sedimentation Rate

29. 29 EHR Message B Dr. Dan Carter John Cohen Patient Record Physician ID Table B Ordering Provider Name B B pointer Dr. Dan Carter Dr. Beth Smyth Dr. … Translate and Store or Store Exactly or Both Version: S-TR/OO-S-MI 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 (OO-S-MI Map received data to value in internal table/file in EHR, then store pointer to referenced value)

30. 30 John Cohen Patient Record Local Code 68590 Message LN 718-8 Lab Test Result EHR Lab Result Mapping Table 68590 12340 718-8 …. 529-8 LN Local …. 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 Translate and Store or Store Exactly or Both Version: S-TR/OO-S-ME pointer

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

33. 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. 34 Use Options NONE (for certification testing) Store Yes Permitted Derivation Action OptionsUse Options Clinical Decision Support Public Health Reporting Display in EHR Other… Not Applicable U-EX Use exact version of stored data; U-TR Translate exact stored data to equivalent value Other… U-REF Use referenced data based on stored pointer U-EQ Use stored equivalent value

35. 35 Requirements for Use - Display Display OptionsDescription U-EX Exact Data SHALL BE displayed to the user by the EHR technology, and what is displayed SHALL BE exactly the same as the text received in the message. U-TR Translate to Equivalent Data SHALL BE displayed to the user by the EHR technology, and these displayed data MAY BE a translation of or equivalent to (rather than exactly the same as) the text received in the message (e.g., if “erythrocyte sedimentation rate” is received in the message “ESR” or “Sed Rate” may be displayed to the user) U-REF Data SHALL BE displayed to the user by the EHR technology, and these displayed data MAY BE referenced data based on stored pointer U-EQ Display Stored Equivalent Data SHALL BE displayed to the user by the EHR technology, and these displayed data MAY BE the equivalent of the text received in the message and stored in the patient record Permitted Data received in a message MAY BE displayed to the user by the EHR technology at the discretion of the EHR vendor. (e.g., the EHR vendor may design their system to display to the user the LOINC code for a laboratory test received in the message)

36. 36 Extra Slides

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

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

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

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

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

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