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1a. Project Name

Laboratory Model / Profiles PSS

1b. Project ID

1539

1c. Is Your Project an Investigative Project (aka PSS-Lite)?

No

1d. Is your Project Artifact being Reaffirmed or proceeding to Normative directly after being either Informative or STU?

No

1e. Today's Date

1f. Name of standard being reaffirmed

1g. Project Artifact Information

1h. ISO/IEC Standard to Adopt

1i. Does the standard include excerpted text from one or more ISO, IEC or ISO/IEC standards, but is not an identical or modified adoption?

1j. Unit of Measure

2a. Primary/Sponsor WG

Orders & Observations

2b. Co-Sponsor WG

Clinical Information Modeling Initiative

2c. Co-Sponsor Level of Involvement

Request formal content review prior to ballot

2c. Co-Sponsor Involvement

Creation of logical models, FHIR profiles, and IG

2d. Project Facilitator

Stan Huff

2e. Other Interested Parties (and roles)

2f. Modeling Facilitator

Nathan Davis

2g. Publishing Facilitator

Nathan Davis

2h. Vocabulary Facilitator

Susan Matney

2i. Domain Expert Representative

2j. Business Requirements Analyst

2k. Conformance Facilitator

Richard Esmond

2l. Other Facilitators

2m. Implementers

3a. Project Scope

The creation of FHIR profiles for the laboratory codes listed in the top 2k LOINC codes as well as their corresponding FHIR profiles and an implementation guide. We will also develop logical models and FHIR profiles for additional labs as resources permit.

Attachments

3b. Project Need

Lab results are routinely sent between systems. There are modeling differences between each lab and specific labs need to be requested from a system. This requires profiles for the labs.

3c. Security Risk

No

3d. External Drivers

3e. Objectives/Deliverables and Target Dates

1. Develop the logical models (complete)
2. Develop the FHIR profiles (complete first draft)
3. QA FHIR profiles with O&O (first draft complete)
4. Develop the IG (complete)
5. Collaborate with implementers, FHIR enable their applications (no date yet).
6. Hold a connectathon (Sept. 2000)
7. Ballot in Jan. 2021

3f. Common Names / Keywords / Aliases:

LOINC, quantitative labs, profiles

3g. Lineage

3h. Project Dependencies

3i. HL7-Managed Project Document Repository URL:

https://github.com/HL7/cimi-labs repo just created, is empty right now.

3j. Backwards Compatibility

No

3k. Additional Backwards Compatibility Information (if applicable)

3l. Using Current V3 Data Types?

Yes

3l. Reason for not using current V3 data types?

3m. External Vocabularies

Yes

3n. List of Vocabularies

LOINC, UCUM, SNOMED

3o. Earliest prior release and/or version to which the compatibility applies

4a. Products

FHIR Extensions, FHIR Implementation Guide, FHIR Profiles, FHIR Resources, Logical Model

4b. For FHIR IGs and FHIR Profiles, what product version(s) will the profiles apply to?

4c. FHIR Profiles Version

R4

4d. Please define your New Product Definition

4d. Please define your New Product Family

5a. Project Intent

Implementation Guide (IG) will be created/modified

5a. White Paper Type

5a. Is the project adopting/endorsing an externally developed IG?

No

5a. Externally developed IG is to be (select one)

5a. Specify external organization

Logica Health (formerly Health Services Platform Consortium)

5a. Revising Current Standard Info

5b. Project Ballot Type

STU to Normative

5c. Additional Ballot Info

5d. Joint Copyright

Yes

5e. I understand I must submit a Joint Copyright Letter of Agreement to the TSC in order for the PSS to receive TSC approval.

Yes

6a. External Project Collaboration

Logica Health, Intermountain Healthcare

6b. Content Already Developed

95%

6c. Content externally developed?

Yes

6d. List Developers of Externally Developed Content

Intermountain Healthcare, Logica Health

6e. Is this a hosted (externally funded) project?

6f. Stakeholders

Clinical and Public Health Laboratories, Standards Development Organizations (SDOs)

6f. Other Stakeholders

6g. Vendors

EHR, PHR, Health Care IT, Clinical Decision Support Systems, Lab, HIS

6g. Other Vendors

6h. Providers

Clinical and Public Health Laboratories, Local and State Departments of Health, Healthcare Institutions (hospitals, long term care, home care, mental health)

6h. Other Providers

6i. Realm

Universal

7d. US Realm Approval Date

7a. Management Group(s) to Review PSS

FHIR

7b. Sponsoring WG Approval Date

May 23, 2019

7c. Co-Sponsor Approval Date

May 23, 2019

7c. Co-Sponsor 2 Approval Date

7c. Co-Sponsor 3 Approval Date

7c. Co-Sponsor 4 Approval Date

7c. Co-Sponsor 5 Approval Date

7c. Co-Sponsor 6 Approval Date

7c. Co-Sponsor 7 Approval Date

7c. Co-Sponsor 8 Approval Date

7c. Co-Sponsor 9 Approval Date

7c. Co-Sponsor 10 Approval Date

7e. CDA MG Approval Date

7f. FMG Approval Date

Nov 13, 2019

7g. V2 MG Approval Date

7h. Architecture Review Board Approval Date

Jun 27, 2019

7i. Steering Division Approval Date

7j. TSC Approval Date