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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
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: [email protected] and [email protected]
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?• 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
RequirementsCommunity SMEs
Transaction Functional
Requirements
Conformance Framework
EHR FunctionalModel
Lab Functional Profile
High-Level
Very Specific
(Applicable to other domains)
Lab Results Interface (LRI) IG
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
AssociateLink/combine specific
data elements received in LRI message
Incorporate
Lab Results
Order
Provider
A B 21
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
• 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
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)
• 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
Sender Receiver
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
45
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
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
IG / Standards
PID.3.1
Defined Requirements
Assigned Requirements
IncorporateDisplay
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
Location Usage
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
Store exact; translate & store translation
Store exact
Translate & store translation
Translate & store translation
Process
Made Available
Indifferent
Exact
Permitted
Exact
Exact
Stored equivalent
Stored equivalent
Permitted
Permitted
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
Exact
Stored equivalent
Stored equivalent
Permitted
Permitted
Permitted
Use
General Process The words “translate”, “translated”, and “translation” may be used differently by different HL7 Workgroups
15
S-MA
S-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
S-MA
S-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 storeOO-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 valueOO-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
Assigning Incorporation Requirement – OBX.3.1
Data ElementStore 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 Choose Data Stored in EHRData
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
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
OR
OBX.3.1Test ID
30341-2
18
Steps in Assigning Incorporation of Received Lab Data in EHR
*See Notes page for legend
Data Elements Incorporation Requirements
PID.3.1 ID# R
PID.3.5 ID Type R
PID.5.2 Given Name R
OBX.5 Obs Value RE
PID.5.1.1 Surname R
Store Action
OBR.7.1 Obs Date/Time R
Location Usage
OBX.3.1 Test ID R
Example Message Data
PID.7.1 DoB 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 REOBX.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
30341-2Erythrocyte sedimentation rate10
millimeter per hour
mm/h
N
Century Hospital
2070 Test Park St.
Los Angeles
CA
90067
S-EX
S-EX-TR
S-EX-TR
S-EX
S-EX
S-EX
S-EX
S-EX-TR
S-EX
S-EX
S-EX
S-EX
S-EX
S-TR
S-EX
S-EX
S-EX
S-TR
Han
s s
ugge
sted
ind
icat
ing
both
Sen
der a
nd R
ecei
ver
Usa
ge
19
Assigning Incorporation Requirement – OBX.3.2
Data ElementStore 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 Choose Data Stored in EHRData
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
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
OR
OBX.3.2Test Text
Erythrocyte sedimentation rate
20
Steps in Assigning Incorporation of Received Lab Data in EHR
*See Notes page for legend
Data Elements Incorporation Requirements
PID.3.1 ID# R
PID.3.5 ID Type R
PID.5.2 Given Name R
OBX.5 Obs Value RE
PID.5.1.1 Surname R
Store Action
OBR.7.1 Obs Date/Time R
Location Usage
OBX.3.1 Test ID R
Example Message Data
PID.7.1 DoB 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 REOBX.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
30341-2Erythrocyte sedimentation rate10
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
S-EX
S-EX
S-EX-TR
S-EX
S-EX
S-EX
S-EX
S-EX
S-TR
S-EX
S-EX
S-EX
S-EX-TR
S-TR
21
Assigning Incorporation Requirement – OBX.5
Data ElementStore 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 Choose Data Stored in EHRData
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
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
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
XXX
22
Steps in Assigning Incorporation of Received Lab Data in EHR
*See Notes page for legend
Data Elements Incorporation Requirements
PID.3.1 ID# R
PID.3.5 ID Type R
PID.5.2 Given Name R
OBX.5 Obs Value RE
PID.5.1.1 Surname R
Store Action
OBR.7.1 Obs Date/Time R
Location Usage
OBX.3.1 Test ID R
Example Message Data
PID.7.1 DoB 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 REOBX.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
30341-2Erythrocyte sedimentation rate10
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
S-EX
S-EX
S-EX
S-EX
S-EX
S-EX
S-EX
S-TR
S-EX
S-EX
S-EX
S-EX-TR
S-TR
S-EX-TR
23
Assigning Incorporation Requirement – OBX.24.1
OBX.24.1 Perf Org Street Address
Data ElementStore 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 Choose Data Stored in EHRData
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
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
OR
24
Steps in Assigning Incorporation of Received Lab Data in EHR
*See Notes page for legend
Data Elements Incorporation Requirements
PID.3.1 ID# R
PID.3.5 ID Type R
PID.5.2 Given Name R
OBX.5 Obs Value RE
PID.5.1.1 Surname R
Store Action
OBR.7.1 Obs Date/Time R
Location Usage
OBX.3.1 Test ID R
Example Message Data
PID.7.1 DoB 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 REOBX.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
30341-2Erythrocyte sedimentation rate10
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
S-EX
S-EX
S-EX-TR
S-EX
S-EX
S-EX
S-EX
S-EX
S-TR
S-EX
S-EX
S-EX
S-EX-TR
25
Century Hospital Laboratory Report
MR# PATID1234 Jones, William (6/15/1961)
3/31/2011 1405 ET
10 mm/h
2070 Test Park StreetLos 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.5.2PID.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
Steps in Incorporation of Received Lab Data and Display in EHR
*See Notes page for legend
Data Elements Incorporation Requirements
Display Requirements
PID.3.1 ID# R
PID.3.5 ID Type R
PID.5.2 Given Name R
OBX.5 Obs Value RE
PID.5.1.1 Surname R
Store Action
OBR.7.1 Obs Date/Time R
Location Usage
OBX.3.1 Test ID R
Example Message Data
PID.7.1 DoB 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 REOBX.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
30341-2Erythrocyte sedimentation rate10
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
U-TR
Not Used
(815117)
U-EX
U-EX
U-EX
U-EX
U-EX
U-EX
U-EX
U-EX
U-EX
S-EX
S-EX-TR
S-EX-TR
S-EX
S-EX
S-EX
S-EX
S-EX-TR
S-EX
S-EX
S-EX
S-EX
S-EX
S-TR
S-EX
S-EX
S-EX
S-TR
27
EHR
Message
Result 10John 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
EHR
Message
Test Name Erythrocyte Sedimentation RateJohn 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
EHR
Message
B Dr. Dan Carter
John Cohen Patient Record
Physician ID Table
B
Ordering Provider Name
BB
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
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
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
EHR
Message
A 123John Cohen
John Cohen Patient Record
A 123matched…& may be discarded
Made Available Version: S-MA
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
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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
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Requirements for Use - Display
Display Options Description
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)
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Extra Slides
37
Yes
Incorporation of DataStore Options
Permitted*
Use of DataUse 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
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
Yes
Incorporation of DataStore 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 DataUse 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
39
Yes
Incorporation of DataStore 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 DataUse 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
40
Yes
Incorporation of DataStore 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 DataUse 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
41
Yes
Incorporation of DataStore 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 DataUse 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
42
Receive Store (in Patient’s Record)
Use*
ABC
*For example, clinical decision support, public health reporting, display in EHR
ABC ABC
ABCEHR Internal TableABC….
ABC abcEHR External Table
ABC….
S-EX
ABC ABC abcEHR Table
ABC
Possible Receive / Store / Use Combinations Diagram
ABC ABC
ABC
S-EX
S-EX-TRABC
OO-S-MI
abcabc
S-EX-TR
ABC
OO-S-ME
Poin
ter
Poin
ter
U-EX
U-TR
U-EX
U-TR
U-REF
U-REF
S-TR
1.
2.
3.
4.
5.