Creation, Maintenance, and Distribution of the Logical Observation Identifiers Names and Codes® (LOINC®) Related to COVID-19

It is the intent of the National Library of Medicine (NLM), to negotiate on a sole source with The Regenstrief Institute, Inc., 1101 W. 10th Street, Indianapolis, IN 46202 under the authority of 6.302-1, Only one responsible source and no other supplies or services will satisfy agency requirements. This acquisition is for the Creation, Maintenance and Distribution of Logical Observation Identifiers Names and Codes (LOINC®) Related to COVID-19. LOINC is a proprietary nomenclature developed by the Regenstrief Institute, Inc. as a source of standard identifiers, names and codes for clinical observations, clinical document types, claims attachment sets and individual questions being asked as part of claims attachments for use in standard administrative health transactions and government and private sector computer-based patient record. This announcement constitutes the only synopsis for this requirement; and is issued for notification purposes only. Any interested party should contact the Contracting Officer below for more information regarding this posting. All correspondence shall be received no later than September 21, 2020 at 12:00 PM EST.

The North American Industry Classification System (NAICS) code for this requirement is 541511: Custom Computer Programming Services. The small business size standard is $30.0 million. **See attached Statement of Work for full description.**

In fiscal year 2019 NLM awarded a five-year contract (75N97019C00012) to the Regenstrief Institute, Inc. to ensure the continued maintenance, expansion, and free public distribution of LOINC. This contract will be supplemental to the 2019 contract. The purpose of this project is the creation and addition of COVID-19-related laboratory test codes to LOINC and development of associated guidelines and training materials for standardized usage. A follow on to the supplemental contract is not anticipated. 

LOINC was first developed by Regenstrief in 1994 to fill the need for moving clinical data generated by laboratories to the hospitals, physician’s offices, and payers who use the data for clinical care and management purposes. NLM’s involvement with LOINC originated through the applications of LOINC as part of broader projects to test the utility of an Indianapolis Regional Network for Primary and Emergency Care (N01-LM-4-3501, N01-LM-6-3546). In FY 1999, NLM awarded a three-year contract to Regenstrief for the continued development and free public distribution of LOINC on behalf of HHS, VA and DOD (N01-LM-9-3517). In FY 2003, NLM awarded a five-year follow up contract to Regenstrief to ensure the continued maintenance, expansion and free public distribution of LOINC (N01-LM-3-3501). NLM awarded subsequent five-year follow-up contracts to Regenstrief in FY 2008 (HHSN276200800006C), FY2014 (HHSN276201400008C), and FY2019 (75N97019C00012). The purpose of this new contract, is to fund COVID-19-related development of LOINC content for one base year with option for one successive one-year option period. This supplemental requirement is set to begin in FY2020.

Regenstrief has unique knowledge and capabilities regarding the development and ongoing maintenance and distribution of LOINC. LOINC is a proprietary nomenclature developed and maintained by Regenstrief and the LOINC Committee, which Regenstrief directs with broad industry input and participation. As previously mentioned, Regenstrief also holds the copyright for LOINC. Therefore, Regenstrief is the only organization capable of maintaining and extending LOINC in order to meet HHS and other federal agency requirements (HHS, VA and DoD all have a vested interest in the LOINC system). There are no other acquisition sources or in-house alternatives. Any other solution would result in substantial duplication costs and unacceptable delays.

Responses to this posting must be submitted via NLM’s Electronic Contract Proposal Submission (eCPS) system at https://ecps.nih.gov, no later than 12:00 p.m., (Eastern-Daylight Savings Time), Monday September 21, 2020.

NOTE:  For directions on using eCPS, go to https://ecps.nih.gov and click on "How to Submit." To submit your electronic proposal using eCPS, all offerors must have a valid NIH External Directory Account, which provides authentication and serves as a vehicle for secure transmission of documents and communication with the NLM. The NIH External Directory Account registration process may take up to three (3) business days to become active. Submission of proposals by facsimile or e-mail is not accepted.

All proposals received within seven (7) days from the date of publication of this synopsis will be considered by NLM. NLM Synopsis No. 75N97020R00024. EMAILS AND FACSIMILES WILL NOT BE ACCEPTABLE. Firms interested in responding to this notice must be able to provide the products and services required by NLM. The offeror shall include all information necessary to document and/or supports the qualification criteria in one clearly marked section of its proposal. All responses from responsible sources will be considered. Inquiries regarding this procurement may be made to the National Library of Medicine, Office of Acquisitions, 6707 Democracy Boulevard, Suite 105, MSC 5488, Bethesda, Maryland 20892, Attention:  Uyen H. Phuong, Contracting Officer, on (301) 496-6546.