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Logical Observation Identifiers Names and Codes (LOINC) for Assessment Data Elements

Awarded
75FCMC26R0050Federal

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This contract is a sole-source, firm-fixed-price acquisition awarded to the Regenstrief Institute, Inc. for the continued maintenance, development, and enhancement of the Logical Observation Identifiers Names and Codes (LOINC) terminology system, a proprietary standard critical to the interoperability of clinical data within electronic health records. The work supports federal mandates under Section 1899B of the Social Security Act and the IMPACT Act of 2014, ensuring standardized, interoperable assessment data elements are available for post-acute care and inpatient psychiatric facilities, particularly through the IPF Patient Assessment Instrument (IPF-PAI), as required by the Consolidated Appropriations Act of 2023. The contract also enables the Quality Improvement Organizations Program to perform quality measurement and care coordination by providing access to a unified, federally recognized clinical data language. Performance will be conducted remotely from Indianapolis, Indiana, where the Regenstrief Institute is headquartered, and the contract runs through 2031 with a total estimated value of $2,130,654, inclusive of all base and option periods. The procurement is justified under FAR 6.302-1 due to the exclusive proprietary ownership of LOINC by the Regenstrief Institute, eliminating other sources capable of maintaining and extending the system. There are no competitive evaluation factors, as award is based solely on the uniqueness of the offering, and no physical packaging, marking, or delivery requirements apply since the deliverables are digital standards and technical services. Oversight is managed by CMS contracting and program personnel in Baltimore, Maryland, with no security clearances or key personnel requirements specified. The contract structure continues a multi-year legacy since 2016 and includes four option periods to ensure uninterrupted support for federal health IT systems, including those of CMS, CDC, VA, and DoD, while maintaining free public access to LOINC codes to foster broad interoperability.

General Info

Sole-source $2.1M contract to Regenstrief Institute for LOINC maintenance to support federal health data interoperability and statutory mandates.

Agency

Department Of Health And Human Services → Ofc Of Acquisition And Grants ManagementView Agency

Contract Value

$400,277

NAICS

541690 - Other Scientific and Technical Consulting ServicesView NAICS

Place of Performance

Indianapolis, IN, 46202, USA

Set-Aside

NONE

Awardee

REGENSTRIEF INSTITUTE INCView Profile

Award Issued Date

Documents

(2)

Solicitation 75FCMC26R0050 Letter of Intent for LOINC Assessment Data Elements

PDFspecial-notice

J&A for Other Than Full and Open Competition - LOINC Assessment Data Elements

PDFjustification-and-authorization

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Timeline

PhaseAwarded
Posted

Justification (J&A)

Awarded

Contract was awarded

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Organization & Contact Information

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AgencyDepartment Of Health And Human Services → Ofc Of Acquisition And Grants Management
Contacts2 people available
OfficeBALTIMORE, MD, 21244, USA
Organization / Agency
Department Of Health And Human Services → Ofc Of Acquisition And Grants Management
View Agency Profile
Office AddressBALTIMORE, MD, 21244, USA

Full Description

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This purpose of this request is for a new Sole Source contract entitled “Logical Observation Identifiers Names and Codes (LOINC) for Assessment Data Elements” to create and update standardized identifiers in the Data Element Library. Developed by the Regenstrief Institute, LOINC codes enable consistent naming and identification to primarily health measurements, laboratory tests, clinical observations, document types, and assessment data in electronic health records for interoperability. This initiative aligns with Section 1899B of Title XVIII of the Social Security Act and the IMPACT Act of 2014, which mandate standardized, interoperable PAC assessment data elements to facilitate coordinated care and improved outcomes. These codes support the standardization of data elements within electronic health records (EHRs), to support the interoperable exchange of information, including assessment information. Additionally, Section 4125(b)(1) of the Consolidated Appropriations Act, 2023 (CAA, 2023) amended section 1886(s)(4) of the Social Security Act to require Inpatient Psychiatric Facilities (IPFs) participating in the IPF Quality Reporting Program to collect and submit standardized patient assessment data, using a standardized patient assessment instrument. The IPF Patient Assessment Instrument (IPF-PAI) has been developed and intended to be implemented in a way to support interoperable exchange of data.
Of additional significance, this project supports the administration of the Quality Improvement Organizations Program (QIO). The Social Security Act, outlined in Part B of Title XI - Section 1862(g), established the Utilization and Quality Control Peer Review Organization Program, now known as the Quality Improvement Organizations Program. The statutory mission of the QIO Program is to enhance the effectiveness, efficiency, economy, and quality of services provided to Medicare beneficiaries.
By linking assessment data elements to standardized health IT terminologies and code sets such as LOINC and SNOMED-CT, CMS provides post-acute and other healthcare providers with critical health IT infrastructure components necessary for exchanging, sharing, and reusing assessment content and other health information. Quality Improvement Organizations (QIOs) can leverage this interoperable assessment content to support quality measurement, care coordination, and performance improvement initiatives throughout the healthcare environment.

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