Exchange Laboratory Test Results

ACLA ISA comment re: added text and definition of harmonization

This text was added under Limitations, Dependencies, and Preconditions for Consideration: “Laboratory test results may require additional information beyond the result value for correct handling and interpretation, including units, reference range, harmonization status of the test, and identifiers for device, test kit, kit version, reagent lot, and calibrator lot. Not all of these elements are included in current messaging standards for the full result reporting path. See “Representing Laboratory Values/Results.”

Please clarify the term “harmonization status”.  We suggest this term be removed until it can be further clarified for expected implementation, clearly measured, etc.  It is too nebulous as currently stated.  For example, can it be measured and if so, how is it validated and how does it relate to the laboratory test results or provider’s EHR system laboratory test results?

Please review the “Applicable Security Patterns for Consideration” applicability to the section and if not applicable, remove.  This would be more appropriate in an introductory section.  This change, if approved, might be applied throughout the document.

Comments for 2021 Reference Edition publication of the ONC (ISA)

Quest Diagnostics, Incorporated collaborated with the American Clinical Laboratory Association (ACLA) to develop 2021 Reference Edition ISA comments (http://www.acla.com/). We support the comments submitted by ACLA. Thank you for the opportunity to provide comments.   

NCPDP Comments

NCPDP supports ONC’s recommendations.

NCPDP Comment

1. Modify the following:

Type-Change to: Implementation Specification

Standard Implementation/Specification- HL7 Implementation Guide for C-CDA Release 2.1: Consolidated CDA for Clinical Notes and C-CDA on FHIR® R4

2. Modify the following:

Type-Implementation Specification

Standard Implementation/Specification- NCPDP Specialized Standard, Implementation Guide, Version 2017071

Implementation Maturity- Production

Comments for 2021 update of the ONC Interoperability Standards A

Quest Diagnostics, Incorporated collaborated with the American Clinical Laboratory Association (ACLA) to develop 2021 ISA comments (http://www.acla.com/).  We support the comments submitted by ACLA. 

Thank you for the opportunity to provide comments.

NCPDP Comment

1. Add the following:

Type-Emerging Standard

Standard Implementation/Specification- HL7 Implementation Guide for C-CDA Release 2.1: Consolidated CDA for Clinical Notes and C-CDA on FHIR R4

Standards Process Maturity – Final

Implementation Maturity- Production

Adoption Level – 1

Federally Required – No

Cost – $

Test Tool Availability – No

Available – Spring 2020

2. Add the following:

Type-Implementation Specification

Standard Implementation/Specification- NCPDP SCRIPT Standard, Implementation Guide, Version 2017071

Standards Process Maturity – Final

Implementation Maturity- Production

Adoption Level – 1

Federally Required – No

Cost – $

Test Tool Availability – Yes

Test Tool Link: https://tools.ncpdp.org/erx/#/home

3. Add the following:

Type-Implementation Specification

Standard Implementation/Specification- NCPDP SCRIPT Standard, Implementation Guide, Version 10.6

Standards Process Maturity – Final

Implementation Maturity- Production

Adoption Level – 2

Federally Required – Yes

Cost – $

Test Tool Availability – Yes

Test Tool Link: https://tools.ncpdp.org/erx/#/home

4. Add the following:

Type-Implementation Specification

Standard Implementation/Specification- NCPDP Specialized Standard, Implementation Guide, Version 2017071

Standards Process Maturity – Final

Implementation Maturity- Pilot

Adoption Level – 1

Federally Required – Yes

Cost – $

Test Tool Availability – Yes

Test Tool Link: https://tools.ncpdp.org/erx/#/home

Update to the most recent version of LRI

Please update to point to the most recent version:

HL7 Version 2.5.1 Implementation Guide: Lab Results Interface (LRI) Release 1, STU Release 3 - US Realm
Link to specification = http://www.hl7.org/documentcenter/public/standards/dstu/V251_IG_LRI_R1_STU3_2018JUN.pdf
Link to DSTU comment page = https://www.hl7.org/dstucomments/showdetail.cfm?dstuid=226

Value Set IG:
Link to specification = http://www.hl7.org/documentcenter/public/standards/dstu/V2_IG_VALUESETS_R1_STU3_2018JUN.zip
For comments on the Value set Companion guide, please submit DST comments under the guide that the vocabulary belongs to - if for the document itself, just pick one of the guides and submit there with the reference to the companion guide document and page number/section or applicable spreadsheet

LRI ISA Update.docx