Logical Observation Identifiers Names and Codes (LOINC) for Assessment Data Elements
Overview
Buyer
Place of Performance
NAICS
PSC
Set Aside
Original Source
Timeline
Qualification Details
Fit reasons
- NAICS alignment with historical contract wins in similar service areas.
- Scope strongly matches core technical capabilities and delivery model.
Risks
- Past performance thresholds may require one additional teaming partner.
- Potential clarification needed on staffing minimums before bid/no-bid.
Next steps
Validate eligibility requirements, assign capture owner, and schedule partner outreach to confirm teaming strategy before submission planning.
Quick Summary
The Centers for Medicare & Medicaid Services (CMS) intends to award a sole-source, Firm Fixed-Price contract to Regenstrief Institute, Inc. for Logical Observation Identifiers Names and Codes (LOINC) for Assessment Data Elements. This critical initiative aims to create and update standardized identifiers in the Data Element Library, enabling consistent naming and identification of health measurements, laboratory tests, clinical observations, and assessment data within electronic health records for enhanced interoperability. This effort supports mandates from the IMPACT Act of 2014 and the Consolidated Appropriations Act, 2023. Vendors who believe they are capable of fulfilling all requirements are invited to submit a written capability statement or objection by June 23, 2026.
Scope of Work
The contractor will be responsible for:
- Creating and updating standardized identifiers in the Data Element Library.
- Maintaining and extending LOINC, a proprietary nomenclature developed and copyrighted by the Regenstrief Institute.
- Supporting the standardization and interoperability of assessment data elements in electronic health records.
- Linking assessment data elements to accepted health IT standards, including LOINC and SNOMED-CT.
- Ensuring compliance with Section 1899B of the Social Security Act, the IMPACT Act of 2014, and the Consolidated Appropriations Act, 2023, particularly regarding standardized patient assessment data for Inpatient Psychiatric Facilities (IPFs).
- Supporting the Quality Improvement Organizations Program (QIO) by providing interoperable assessment content for quality measurement and care coordination.
Contract & Timeline
- Type: Firm Fixed Price (FFP), Sole Source.
- Proposed Contractor: Regenstrief Institute, Inc.
- Acquisition Period: 2027-2031.
- Estimated Total Value: $2,130,654.00.
- Product Service Code: R499 - Other Professional Services.
- Published Date: June 16, 2026.
- Submission Deadline for Capability Statements: June 23, 2026, 11:00 AM Eastern Standard Time (EST).
- Place of Performance: Indianapolis, IN.
Set-Aside & Rationale
This is a Sole Source acquisition, citing FAR 6.302-1(a)(2) - Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements. The rationale is that Regenstrief Institute holds the copyright and proprietary rights to LOINC and is the only organization capable of maintaining and extending these codes to meet agency requirements. Market research confirmed their unique capabilities.
Submission & Evaluation
Vendors must submit a written capability statement or objection to the Contracting Officer by the deadline. Oral communications will not be accepted. CMS will review submissions to determine if any other source can meet the agency's needs without substantial duplication of costs or unacceptable delays. A Justification for Other Than Full and Open Competition (JOFOC) has been approved. CMS will not reimburse any costs associated with proposal preparation or submission.