JOFOC_FY26 One Lambda - Copy.docx

POTS: 26-000027

Justification for Other than Full and Open Competition “Source Selection Information – see FAR 2.101 and 3.104”

1. Identification of the agency and contracting activity.

a. Federal agency and contracting activity.

Department of Health and Human Services National Institutes of Health Clinical Center Department of Transfusion Medicine/HLA Lab

b. Sponsoring organization.

Health and Human Services National Institutes of Health Clinical Center Purchasing and Contracts Department 6701 Democracy Blvd Bethesda, MD 20892-4874

c. Project Officer information.

· Telephone number: (301) 496-8852

2. Nature and/or description of the action being approved.

a. Acquisition purpose and objectives. The purpose of this acquisition is for the NIH HLA Lab to obtain a one year supply of HLA typing and antibody screening reagents from One Lambda (vendor). The vendor will provide all reagents and supplies stated on the quote on an “as needed/requested” basis. This will ensure the HLA Lab will maintain sufficient stock for patient testing. The period of performance for this contract is estimated to be June 2026 to May 2027.

b. Project background. The NIH HLA Lab currently uses the reagents and supplies from One Lambda. These have been extensively quality control tested to validate performance.

3. Description of the supplies or services required to meet the agency’s needs (including the estimated value).

a. Project title. Acquisition of One Lambda Reagents for HLA Typing and Antibody Screening of NIH Transplant Protocols.

Project description. The National Institutes of Health (NIH) is the nation’s foremost federally funded biomedical research institution. It is comprised of twenty-seven Institutes and Centers. The NIH Clinical Center (CC) is the onsite hospital for the NIH campus, providing full support for clinical studies in inpatient and outpatient settings. The NIH CC is an 870,000 square-foot facility with the capacity to serve 240 inpatient beds and 82 day-hospital stations.

The function of the Human Leukocyte Antigen Laboratory (HLA) of the Department of Transfusion Medicine, CC is to (1) provide clinical diagnostic laboratory testing for patients in the Clinical Center to facilitate possible transplant or enrollment into an appropriate protocol for the patient’s particular condition; (2) to conduct clinical consultations for Clinical Center physicians in the management of patient care in regards to potential transplant scenarios; (3) to maintain accreditation through various accrediting agencies in order to provide quality results (4) to conduct research in the development of new diagnostic laboratory tests (5) to facilitate the support and development of protocols which involve HLA testing and the implications for patient care.

· Requirement type.

Research & development (R&D) R & D support services Support services (non-R&D) X Supplies/equipment Information technology (IT) Construction Architect-engineer (A & E) services Design-build Other (specify): ____________________

· Type of action. Check the appropriate box:

X New requirement Follow-on Other (specify): ______________________

· Proposed contract/order type. Check all that apply:

X Firm-fixed-price Other fixed-price (specify, e.g., fixed-price award-fee, fixed-price incentive-fee): __________ Cost-plus-fixed-fee Other cost reimbursement (specify, e.g., cost-plus-award-fee, cost-plus-incentive-fee): ___________ Time and materials Indefinite delivery (specify whether indefinite quantity, definite quantity, or requirements): ___________ Other (specify): ___________ Completion Form Term form

· Acquisition identification number. 26- Reagents will be received on an “as needed/requested” basis.

4. Demonstration that the proposed contractor(s) unique qualifications or the nature of the acquisition requires use of the authority cited.

a. Name and address of the proposed contractor(s).

One Lambda, Inc 22801 Roscoe Blvd West Hills, CA 91304-3200

b. Nature of the acquisition and proposed unique qualifications of the contractor(s).

The reagents requested are the reagents currently in use in the NIH HLA Lab for routine HLA typing and antibody screening. These reagents provide the information required by researchers to initiate transplantation workups as per their protocols.. This level of testing increases the probability of a successful transplant.

One Lambda is the only manufacturer of these specific HLA typing and antibody screening reagents. The HLA Lab currently uses these reagents to test our patients. The reagents provided by One Lambda have been previously tested in the lab and provide a greater ability to resolve testing ambiguities than other vendors tested. All validation testing has been completed for these reagents so there is laboratory documentation available to confirm the accuracy and precision of these reagents. A change in vendors/reagents would require extensive validation and would take approximately 2 months. This would greatly impact the ability of the HLA Lab to provide timely results.

5. Description of the efforts made to ensure that offers are solicited from as many potential sources as practicable. Indicate whether a FedBizOpps notice was or will be publicized as required by FAR Subpart 5.2 and, if not, which exception under FAR 5.202 applies.

One Lambda is the sole provider of the LABType, LABScreen and Secore kits. No other vendors would be suitable.

6. Description of the market research conducted (see FAR Part 10) and the results, or a statement of the reasons market research was not conducted.

These exact reagents are not available from any other vendor and have been quality control tested to validate their performance. To change vendors for a similar reagent kit would require extensive testing and validation of the new reagents which would impact patient care.

7. Program office certification. This is to certify that the portions of this justification that have been developed by the undersigned program office personnel, including supporting information and/or data verifying the Government’s minimum needs, schedule requirements and other rationale for other than full and open competition, are accurate and complete.

Project Officer

Project Officer’s Immediate Supervisor

Head of the Sponsoring Program Office

8. Contracting Officer certification. This is to certify that the justification for the proposed acquisition has been reviewed and that to the best of my knowledge and belief the information and/or data provided to support the rationale and recommendation for approval is accurate and complete.

Contracting Officer

9. Chief of the Contracting Office and Head of the Contracting Activity signature(s).

Chief of the Contracting Office

Head of the Contracting Activity