S&I Framework LRI Validation Suite Vocabulary Testing Proposal (Lab Results Interface) Robert...

S&I Framework LRI Validation SuiteVocabulary Testing Proposal (Lab Results Interface)

Robert Snelick

National Institute of Standards and Technology

February 28th, 2012

Contact: [email protected]

2

How do we Test the Required Vocabulary Standards?• Limit discussion to LOINC

– In particular the use of LOINC for the observation result identifier (OBX.3)

• How do we interpret the Meaningful Use Requirements?– “Incorporate results. Electronically attribute, associate, or link a laboratory test result to a

laboratory order or patient record.”– How do we ensure that the LOINC codes are used meaningfully? How do we ensure this:

• “The LOINC code is the anchor that discretely and accurately identifies the lab test that was ordered/performed. No matter what a hospital or physician chooses to call the test, the LOINC code is the one constant that tells everyone which test it was.”

• How do we test the sender (the LIS)?• How do we test the receiver (the EHR)?• How do we test the universe of possible codes?• Considerations:

– Meaningful Use Requirements– Labs and EHR use local codes today– EHR likely to translate/map LOINC code to local code and display local text name on user’s

screen (what impact does this have on testing?)

• Two perspectives I’ve heard from the community:– “LOINC codes should not be tested for “correct” values, just that it is a valid LOINC code”—

what is the purpose of the standardized code then?– “If local codes are sent and used in conjunction with the standardized codes then we are no

closer to achieving terminology interoperability”

3

Meaningful Use Requirements• LOINC is a named standard for lab test results in the §170.306.g Reportable Lab

Results Stage 1 ONC certification criterion.• The §170.302 (h) Incorporate laboratory test results criterion states:

– Receive results. Electronically receive clinical laboratory test results in a structured format and display such results in human readable format.

– Display test report information. Electronically display all the information for a test report specified at 42 CFR 493.1291(c)(1) through (7).

– Incorporate results. Electronically attribute, associate, or link a laboratory test result to a laboratory order or patient record.

• The criteria use the following verbiage when referring to LOINC: – “§170.306 (g) Reportable lab results. Electronically record, modify, retrieve, and submit reportable

clinical lab results in accordance with the standard (and applicable implementation specifications) specified in §170.205(c) and, at a minimum, the version of the standard specified in §170.207(c).”

– §170.207(c) states: “Standard. Logical Observation Identifiers Names and Codes (LOINC®) version 2.27, when such codes were received within an electronic transaction from a laboratory (incorporated by reference in §170.299).”

– In the ONC Final Rule Preamble for 170.304.i Exchange Clinical Information and Patient Summary Record ONC stated the following:• “For the purposes of electronically exchanging a patient summary record, we expect the patient summary record to

include health information that is coded, where applicable, in accordance with adopted vocabulary standards. Therefore, unless otherwise required in the context of a meaningful use objective and measure, an eligible professional (or eligible hospital) would be permitted to map or crosswalk local/proprietary codes to the adopted vocabulary standards prior to transmitting a patient summary record.”

– MU Stage-2 requirements are not finalized (See the last slide for a summary of current discussions)

4

Testing LOINC—LIS (Sending Application) • Lab Test Order (options)

– Test case will indicate a lab test order on a paper form– Test case may indicate the lab test order in electronic format

• This is simulated (i.e., it is assumed that the LIS received the order)?• A specific LOINC code in OBR.4 may be specified (Lab dependent)

• Lab Results– Test Case will provide lab test order/results data sheet (indicates all the

results of the lab test)– A LIS user enters the information into the LIS system (including the

appropriate LOINC code for the order)– The LIS system generates an LRI message

• Validation– The message is imported in the LRI LIS validation tool– The LIS LRI validation tool validates the message– For LOINC the validation tool will examine the content of OBX.3 for a valid

observation identifier (LOINC code)

5

Testing LOINC—LIS (Sending Application) • For a given order request a finite number of valid observation identifiers

(LOINC codes) are identified and associated with that order• For example if the order requested is a Hemoglobin in blood test (LOINC

code is 718-7) then the following LOINC codes would be considered valid:

LOINC Code Test Long Name718-7 Hemoglobin [Mass/volume] in Blood (Methodless)

20509-6 Hemoglobin [Mass/volume] in Blood (by Calculation)30313-1 Hemoglobin [Mass/volume] in Arterial blood (Methodless)30352-9 Hemoglobin [Mass/volume] in Capillary blood (Methodless)30351-1 Hemoglobin [Mass/volume] in Mixed venous blood (Methodless)30350-3 Hemoglobin [Mass/volume] in Venous blood (Methodless)

• The LRI LIS validation will check OBX.3 (OBX.3.1 or OBX.3.4) for one of the listed LOINC codes for this test case

• The LRI LIS validation tool in-scope tests are limited to the most common lab tests (i.e., the entire LOINC database is not in scope) for testing

• The list of the in-scope lab tests and their respective LOINC codes can be found in a spreadsheet located on the validation suite WG wiki• Current version: Categorized Tests for LRI Testing Compiled ST v11.xlsx

1. Test tool can give guidance—default to expert

2. Verify LOINC mappings with Regenstrief

6

LIS Validation Tool Test Flow (Context Based)

LIS

LIS Test Tool select test case

Test Data Sheet

Manual entry of test data

Load Cut/paste Send

HL7 V2 Lab Results Message

Use Case

Test Case

ValidationReport

EHR transmits Hemoglobin blood test order to the LIS for John Doe along with pertinent demographic and order request data

Lab Results Data SheetJohn DoeDOB: 05/23/1959Gender: MResult: 13.7 g/dL Range 13.2 – 16.2Status: Final

• A lab test is ordered for a patient• The specimen is collected, and is received and processed in the lab• The lab result is produced and stored in the LIS database•The lab result is transmitted to an ambulatory EHR•The lab result is viewed in the ambulatory EHR

1. Local code2. No code—text3. LOINC code

No LOINC given for results

• Test tool inspects OBX.3 for a specific LOINC code• Inspect for 718-7 only or inspect for one of 718-7, 20509-6, 30313-1, 30352-9, 30351-1, and 30350-3?

For Discussion:1. No suggested method given (Should we?)2. With no method given we should expect one

from a set of valid LOINC codes for this order (Lab dependent?)

3. If a specific method is given (is this typical/possible?) then should we look for a specific LOINC code in the sent message?

For Discussion:1. Does the LAB expect a local code for the order in

a electronic order request?2. Use Cases to consider: agreement/no agreement

between LIS and EHR for local codes

It is assumed Lab has capabilities for manual entry

Dat

a E

ntry DB

Message

http://www.clker.com/clipart-11378.html

7

Validation of LOINC for Sender of OBX.3

• Requirements from LRI IG (OBX.3) – Usage: R; Datatype: CWE– Unique identifier for the type of observation. This field provides a code for

the type of observation. OBX-3 in conjunction with OBX-4 Observation Sub-ID should uniquely identify this OBX from all other OBXs associated with this OBR.

– LOINC is used as the coding system for this field. Local codes may also be used in conjunction with LOINC codes

– When populating this field with values, this guide does not give preference to the triplet in which the standard (LOINC) code should appear.

• Example: 718-7^Hemoglobin [Mass/volume] in Blood^LN• Validation (For context-based testing)

1. Valid LOINC code for the lab test ordered (one of a pre-determined set)

2. Valid OBX.3.1 and OBX.3.2 pair (or OBX.3.4 and OBX.3.5 pair)

3. Valid LOINC format (subsumed by 1)

4. Valid LOINC code from LOINC database (subsumed by 1)

8

Testing LOINC—EHR (Receiving Application) • Lab Result LRI test message is sent to the EHR

– Test case will indicate the lab result in a data sheet– A LRI message is generated and sent to the EHR– Message will contain a LOINC code in OBX.3 (observation identifier) UPDATE: Maybe

not, in fact uses a local code in one message and a LOINC code in another might provide the test case (show aggregated results)

• How to test that the EHR incorporates the LOINC code?– Option 1: Send only the LOINC code in OBX.3

• EHR can translate into internal code and display local text string of lab test name• If only the LOINC code is sent then this provides a mechanism to better ascertain that the EHR

incorporated the LOINC code (since no local code is provided) UPDATE: yes, since system may use LOINC internally and if not they have to provide the mapping (maybe send without text?)

• EHR can use LOINC code directly

– Option 2: Send a LOINC code and local code in OBX.3• Is this a necessary option? Can the actual incorporate be circumvented? UPDATE: probably not a useful

test case at all

• Validation (details to follow)– The lab results are inspected by viewing the EHR display (GUI)– Certain elements can be displayed as equivalent concept (e.g., lab test display name)– Certain elements are to be displayed exactly as received (e.g., result and units)

9

LRI EHR Test Harness Test Flow—Testing the EHR (Model 1)

EHRLab Message

ACK

Validation

LRI EHR Test Harness

CommunicationLRI Test

Message

Validation Report

Test Data

Test Case

Use Case

JurorDocument

ACK

718-7 (LN)

718-7 (LN)

718-7 (LN)S Name Value REF Range

F Hemoglobin 13.7 13.2 – 16.2 g/dL

For Discussion:1. What are the requirements on the EHR with regards to LOINC—

given the LRI IG, CLIA, and meaningful use? 2. What are the EHR display (GUI) requirements for the received lab

results?3. What are the EHR storage requirements for the received lab

results?4. Given that the LOINC code is likely to be translated into the EHR

internal representation, what lab test names need to be displayed in exact form and what lab test names can be displayed in an equivalence text (same concept)?

5. What qualifies as “equivalence—same concept”? How is that determined? Can it be? Expert inspector only? Should displaying of the LOINC text (only) be the requirement—i.e., no mapping?

6. What is the impact of sending only the LOINC code (i.e., no local code) on testing?

Translated into internal

representation

Displayed as internal display text representation


10

Processing of Standardized Vocabulary (Proposed)• Receiver requirements for Standardized Vocabulary:

– The receiver shall persist (store) the original standardized code and the original standardized code text as received in exact representation UPDATE: No, I don’t think this is a requirement. The receiver could use/store it’s local code but have the capability to translate into LOINC whenever necessary. This provides an equivalent capability.

– The receiver may perform a translation/mapping to a locally defined representation UPDATE: Yes, but LOINC has to be the anchor

– If a translation is performed the concept of the original standardized code shall be maintained UPDATE: Yes

11

Assessment of Standardized Vocabulary (Proposed)• Procedure for assessing the receiver for incorporation of standardized

vocabulary:– Note: discussion is limited to standardized vocabulary (i.e., the LOINC code received and

associated components, e.g., the display text). The lab results values are not in scope for this discussion.

– Where applicable to meet CLIA and MU requirements the receiver shall display on the EHR GUI the equivalent representation of the received coded lab test name. The receiver shall display at least one of the following:• Original standardized code text• Original standardized code (probably not very useful, but is it acceptable?)• Local code text (local display representation)

– UPDATE: one of the following:– The receiver shall be capable of demonstrating the persistent of the original standardized

code and the original standardized code text. Acceptable methods for attestation:• Administrative access to database• Inspector approved method• UPDATE: test case showing aggregation of test results (See SLIDES to follow)

– If applicable the receiver shall be capable of demonstrating the linkage of the original standardized code and the locally translated/mapped code. Acceptable methods for attestation:• Administrative access to database• Browse capabilities of configuration files• Inspector approved method• UPDATE: test case showing aggregation of test results (See SLIDES to follow)SEE NEXT SLIDE FOR UPDATED PROPOSAL (To replace this slide????)

12

Assessment of Standardized Vocabulary (Proposed II)• Procedure for assessing the receiver for incorporation of standardized vocabulary:

– Note: discussion is limited to standardized vocabulary (i.e., the LOINC code received and associated components, e.g., the display text). The lab results values are not in scope for this discussion.

– Where applicable to meet CLIA and MU requirements the receiver shall display on the EHR GUI the equivalent representation of the received coded lab test name. The receiver shall display at least one of the following:• Original standardized code text• Original standardized code (probably not very useful, but is it acceptable?)• Local code text (local display representation)

– The receiver shall demonstrate that the LOINC code is the anchor that discretely and accurately identifies the lab test that was ordered/performed. No matter what a hospital or physician chooses to call the test, the LOINC code is the one constant that tells everyone which test it was. Attestation requirements:• (A) The receiver shall be capable of demonstrating that LOINC is used natively to import, attribute, associate, or link lab

results. OR• (B) The receiver shall be capable of demonstrating that the LOINC code is the anchor to import, attribute, associate, or link

lab results (A mapping table or external mapping service are acceptable means). AND• The EHR may store of the original standardized code or if applicable the receiver shall be capable of demonstrating the

linkage of the original standardized code and the locally translated/mapped code. Acceptable methods for attestation:– Administrative access to database– Browse capabilities of configuration files– Inspector approved method

• The receiver shall be capable of performing computable activities on received LOINC results (e.g., test case showing aggregation of test results (See SLIDES to follow))

• The receiver shall be capable of instantiating correct LOINC codes in messages and documents being sent from the EHR (e.g., test using MU workflow—reportable labs and CDA)

• The receiver shall not break when receiving an unknown LOINC code - displaying the text description of the lab test if the received LOINC code is not recognized by the EHR (text description as provided in the received message)

13

What does Equivalent Representation (Concept) Mean?• The exact original code• The exact original code text (Make this the only acceptable method?)

UPDATE: Probable not; it is unnecessary

• For translated/mapped local code text an equivalent representation as determined by a clinical terminology expert. The following rules and guidance are given to promote consistency in assessment:– Rule: A terminology shall never be made more specific in the

translation/mapping.– Rule: A terminology shall never be made more specific in the display of

standardized terminology.– Guidance: A limited number of synonyms are provided to assist the clinical

terminology expert. Note: a predefined finite set is not possible—there are too many possible equivalent local representations.

– Guidance: The inspector must consider the context in which the code is used as this may impact the translation/mapping.

14

Discussion (Mapping to a more general code)

• What should be the assessment if a specific terminology code is received that is mapped to a less specific code? – For example, 30351-1 (Hemoglobin [Mass/volume] in Mixed venous blood) to 718-7

(Hemoglobin [Mass/volume] in Blood)• Assuming this is relevant

– This mapping will lead to a loss of information if the original code is not persisted. – Is it valid to display a representation that has less specificity? – Is it valid to display a representation that has less specificity as long as the original

data is persisted in the system? – Is it acceptable for a loss of information to occur when data is rendered as a report or

forwarded on to another system (e.g., public health)? That is, we sent a specific code and then a general code is forwarded on to public health. Is it acceptable for either the general or specific LOINC code to be forwarded?

• LOINC codes often indicate a specific processing method for a particular lab test; the NLM has recommended use of LOINC codes that do not specify a method (i.e., are “method-less”)– What is the testing impact? – Do we focus on the general codes? – Does method-less mean less specific?

15

Proposed Test Cases

• Send single message LOINC code only• Send two messages (expect to see aggregate results)

– LAB-A Local Code– LAB-B LOINC Code

• Send two messages (expect to see aggregate results)– LAB-A Local Code– LAB-B Local Code

• Send two messages (expect to see aggregate results)– LAB-A LONIC (same) Code– LAB-B LOINC (same) Code

• Send two messages (expect to see aggregate results)– LAB-A LONIC (different) Code– LAB-B LOINC (different) Code

• Test workflow of reportable lab results to public health– Use LOINC or local code only

• Test workflow of Lab CCD (MU-2 Consolidated CDA?) document– Use LOINC or local code only

16

Test Case Proposal for LOINC incorporation – Case 0

EHR

EHR is expected to map LOINC to local

and display local text or display LOINC text718-7 (LN)

Lab Results for Hemoglobin

S Name Value REF Range Ab Date

F Hemoglobin 16.7 13.2 – 16.2 g/dL A 02/24/2012

For Discussion:1. Test case is set up to send lab results for hemoglobin2. Lab – A sends the results using the LOINC code only for the hemoglobin test on March 3 rd, 20123. The EHR is expected to display the LOINC text name or map to an internal code an then display the internal test name4. Note: LOINC does not need to be the internal code for the lab result that is linked to the patient record; it is OK for the internal

code to be translated as needed.


LRI EHR Test HarnessSimulated Test Lab - A

Hemoglobin Lab Result for Patient PAT-1234 on

03/03/2012

718-7 (LN)

LRI Test Message A

XY7187 (L)

718-7 (LN)

718-7 (LN)

17


EHR

EHR is expected to link and aggregate

the results


LRI Test Message A


02/24/2012

718-7 (LN)

XY7187 (L)




F Hemoglobin 15.2 13.2 – 16.2 g/dL N 03/03/2012

For Discussion:1. Test case is set up to send lab results for the same test from two different labs on different dates2. Lab – A sends the results using their local code only for the hemoglobin test on February 24 th, 20123. Lab – B sends the results using the LOINC code only for the hemoglobin test on March 3 rd, 20124. The EHR is expected to link the results given that they are for the same test. An EHR can demonstrate that the results have been

link by providing an aggregation of the results (e.g., a consolidated tables of hemoglobin results or a graph over time)— is this a MU requirement?—UPDATE: may not be a MU requirement but this is a valid approach (i.e., EHR can demonstrate using this method)

5. If this can be demonstrated then can we make the assumption that LOINC has been incorporated into the EHR6. Note: LOINC does not need to be the internal code for the lab result that is linked to the patient record; it is OK for the internal



LRI EHR Test HarnessSimulated Test Lab - B


03/03/2012

718-7 (LN)

XY7187 (L)

LRI Test Message B

XY7187 (L)

718-7 (LN)

XY7187 (L) Pre-test setup indicates that the LIS - A and the EHR negotiated XY7187 as the code for hemoglobin

18


EHR


the results


LRI Test Message A


02/24/2012

RS7187 (L)

XY7187 (L)





For Discussion:1. Test case is set up to send lab results for the same test from two different labs on different dates2. Lab – A sends the results using their local code only for the hemoglobin test on February 24 th, 20123. Lab – B sends the results using their local code only for the hemoglobin test on March 3 rd, 20124. The EHR is expected to link the results given that they are for the same test. An EHR can demonstrate that the results have been


5. If this can be demonstrated then can we make the assumption that LOINC has been incorporated into the EHR (or can we?)6. Note: LOINC does not need to be the internal code for the lab result that is linked to the patient record; it is OK for the internal





03/03/2012

RS7187 (L)

XY7187 (L)

LRI Test Message B

XY7187 (L)

RS7187 (L)

XY7187 (L) Pre-test setup indicates that the LIS - A and the EHR negotiated XY7187 as the code for hemoglobin and LIS – B negotiated RS7187 as the code for hemoglobin RS7187 (L)

718-7 (LN)

EHR could link to LOINC but could also link to an internal code

19


EHR


the results


LRI Test Message A


02/24/2012





For Discussion:1. Test case is set up to send lab results for the same test from two different labs on different dates2. Lab – A sends the results using the LOINC code only for the hemoglobin test on February 24 th, 20123. Lab – B sends the results using the LOINC code only for the hemoglobin test on March 3 rd, 20124. The EHR is expected to link the results given that they are for the same test. An EHR can demonstrate that the results have been







03/03/2012

LRI Test Message B

718-7 (LN)

Since LOINC is the only code sent aggregation is not possible unless LONIC is supported either natively or mapped to an internal code system? Correct?

718-7 (LN)

718-7 (LN)

718-7 (LN)

718-7 (LN)

20


EHR


the results


LRI Test Message A


02/24/2012





For Discussion:1. Test case is set up to send lab results for the same test from two different labs on different dates2. Lab – A sends the results using the LOINC code (718-7 – general) only for the hemoglobin test on February 24 th, 20123. Lab – B sends the results using the LOINC code (30350-3 – Venous) only for the hemoglobin test on March 3 rd, 20124. The EHR is expected to link the results given that they are for the same test. An EHR can demonstrate that the results have been







03/03/2012

LRI Test Message B

718-7 (LN)

Both labs sent LOINC codes for hemoglobin but they are different. The EHR is expected to aggregate results. What does this tell us about the “incorporation” of LOINC?

30350-3 (LN)

718-7 (LN)

30350-3 (LN)

718-7 (LN)

30350-3 (LN)

21

We propose to Leverage MU Stage-1 Requirements

LAB(or any sending system or tool)

EHR(System under Test)

Public Health

HL7 ELR IG 2010

Direct Data Entry

ORU Message ORU Message

ORU Message Elements

1. Meaningful Use Stage-1 requirements includes the EHRs to send reportable lab results to public health using the HL7 Version 2.5.1 Implementation Guide: ELR to Public Health (Release 1: February 2010)

2. NIST test tool already exists and used for Meaningful Use stage-1 certification3. Identify which test cases fall into the category of reportable lab results4. Identify the differences in the implementation guides (data elements, etc.)5. Provide data sheet for additional information that needs to be entered into the EHR system6. Correlate content of public health message to original LRI test case message7. This process provides additional automated testing8. Test EHR workflow

ORU Elements

Meaningful Use ScopeStage 1

NIST Message Validation Tool


S&I Framework LRI

22


EHRLab Message

ACK

Validation



Message

Validation Report

Test Data

Test Case

Use Case

JurorDocument

ACK

718-7 (LN)

718-7 (LN)718-7 (LN)

S Name Value REF Range


For Discussion:1. Employ a testing technique that leverages other EHR capabilities and

MU requirements2. In this case, leveraging reportable lab results to public health3. It is expected that the EHR send exactly the same LOINC code as it

received?4. Can the EHR translate a specific LOINC code to a general LOINC code?5. In general, what transformation rules are acceptable if any?


representation Displayed as internal display text representation

MU-1 Public Health

Message

Public Health Lab Message

Validation Tool

718-7 (LN)


23

LRI EHR Test Harness Test Flow—Testing the EHR (Model 2’)

EHRLab Message

ACK

Validation



Message

Validation Report

Test Data

Test Case

Use Case

JurorDocument

ACK

XY7187 (L)

XY7187 (L)XY7187 (L)




MU requirements2. In this case, leveraging reportable lab results to public health3. It is expected that the EHR send an equivalent LOINC code based on

the local code it received?4. In general, what transformation rules are acceptable if any? We can

narrow down the “acceptable” codes based on the test.


representation Displayed as internal display text representation

MU-1 Public Health

Message

Public Health Lab Message

Validation Tool

718-7 (LN)

718-7 (LN)Maps Code

Validation Suite Call 02/28/2012: Group agreed this is a valid method; also noted that lab may send to public health directly but EHR (per MU) also is required


24

We propose to Leverage MU Stage-1 CCD Requirements

LAB(or any sending system or tool)

EHR(System under Test)

Direct Data Entry

ORU Message

Create CCD

ORU Message Elements

1. Meaningful Use Stage-1 requirements states the EHR shall to a CCD (for MU-2 a consolidated CDA). For MU-2 we could use the consolidated CDA (CCD may not apply anymore).

2. NIST CCD test tool already exists (CDA to be built) and used for Meaningful Use stage-1 certification; however not for content testing. This feature needs to be added to validate results based on data provided in ORU test message (in particular the LOINC code—regardless if present in test).

3. Identify the data elements that map between the LRI IG and CCD (CDA) Lab Document4. Provide data sheet for additional information that needs to be entered into the EHR system5. Correlates content of CCD (CDA) to original LRI test case message6. This process provides additional automated testing7. Tests an EHR workflow

ORU Elements


NIST CCD Validation ToolMeaningful Use Scope

Stage 2

S&I Framework LRI

Create CDA


NIST CDA Validation Tool

Add/or

25


EHR

Lab Message

ACK

Validation



Message

Validation Report

Test Data

Test Case

Use Case

JurorDocument

ACK

XY7187 (L)

XY7187 (L)XY7187 (L)




MU requirement (leveraging the creation of a CCD (CDA) Lab Document)

2. The EHR vendor provides a mapping of a Local code (XY7187) for a selected LOINC lab result code (718-7)

3. A test message is sent using only the local code. The EHR is expected to map the local code to the LOINC code

4. A request is made to the EHR to generate a CCD (CDA) document based on the lab results received. The LOINC code is expected in the CCD (CDA)

Translated into internal representation


MU-1 LABCCD (or CDA)

CCD (CDA) Lab Validation Tool

718-7 (LN)

718-7 (LN) LOINC code is expected (required)

in CCD (CDA)Maps Code

Note: CCD applies to MU-1; Consolidated CDA to MU-2


26

Other Issues for Testing Standardized Vocabulary• EHR – Options for implementing standardized vocabulary

– Use standardized coding internally– Map to local codes– Need to account for options in test procedure

• How do we test for complete coverage of recommended standardized vocabulary?– Create all messages for all possible (recommended) terms (for important code system,

e.g., LOINC)—This is the preferred approach– Alternative approach: Create a subset and inspect/verify configuration tables for

coverage and accuracy– The LAB is not restricted to sending the recommended list of LOINC codes and the

EHR should not fail when it does not recognize a LOINC code. • How can this be tested; should it be tested?

– We should test that the EHR recognizes an invalid LOINC code and rejects the message.• Given that LOINC changes often what mechanisms will a system use to identify invalid codes (based on a

certain format?)• We could send messages where code and text don’t match as another negative test

– Selection of approach may be made on a case-by-case analysis – It may be necessary to provide coverage for all recommended LOINC codes. However,

for other vocabularies it may not be a priority (e.g., state) or may not be feasible (SNOMED). What is the testing approach?

27

NIST’s understanding of the request from the Vocabulary Task Force (For Meaningful Use Stage-2)EHR MU Capabilities Discussed on June 6th 2011 TF call:• Require that an EHR be capable of understanding a subset of 2000 most

commonly used LOINC codes for lab results reporting– Subset would be published by Regenstrief (see LOINC Mapper’s Guide to Top

2000+ Lab Tests v1.0a)

• EHR would need to be capable of *– R1: performing computable activities on received LOINC codes - storing LOINC codes

received in a lab results message in such a way that the EHR can perform computable activities on the received LOINC codes

– R2: don’t break if receive unknown LOINC code - displaying the text description of the lab test if the received LOINC code is not recognized by the EHR (text description as provided in the received message)

– R3: transmitting LOINC codes - instantiating correct LOINC codes in messages and documents being sent from the EHR

* Note that the required capabilities are still being discussed in the Vocabulary TF. The criterion statements have not been written by ONC. This is NIST’s understanding as of 06/06/2011

Source: Ken Gebhart, NIST

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