Sole Source Justification- Shady Grove 2026.pdf

Date: 05/07/2026

Subject: SOLE SOURCE JUSTIFICATION AND APPROVAL

To: NIH, CLINICAL CENTER, CONTRACTING OFFICER

1. AGENCY IDENTIFICATION AND CONTRACTING ACTIVITY

Requiring Activity:

National Institute of Health Clinical Center 9000 Rockville Pike Bethesda, MD 20814

Contracting Activity:

National Institute of Health Office of Purchasing and Contracts 6707 Democracy Blvd Bethesda, MD 20892

2. NATURE AND/OR DESCRIPTION OF THE ACQUISITION BEING APPROVED

Oocyte storage and freezing for NIH patients.

3. DESCRIPTION OF THE SUPPLIES AND SERVICES REQUIRED TO MEET THE AGENCY’S NEEDS

The Contractor shall provide qualified personnel, services, materials, equipment and supplies necessary to process eggs harvested by WRNNMC staff, freeze the eggs and store them, until such time as the patient or their heirs request delivery or disposal of the eggs. The Contractor shall supply all labor, materials, equipment and supervision for developing and staffing a laboratory on site at WRNMMC.

IDENTIFICATION OF STATUTORY AUTHORITY PERMITTING OTHER THAN FULL AND OPEN

COMPETITION.

FAR 13.106-1(b) (1): For purchases not exceeding the simplified acquisition threshold (SAT), contracting officers may solicit from one source if the contracting officer determines that the circumstance of the contract action deem only one source reasonably available (e.g. urgency, inclusive licensing agreements, brand name, or industrial mobilization).

4. DEMONSTRATION THAT THE PROPOSED CONTRACTOR’S UNIQUE QUALIFICATIONS OR THE

NATURE OF THE ACQUISITION REQUIRES USE OF THE AUTHORITY CITED

The Clinical Center has a clinical support team to address a broad variety of routine medical issues that may arise during a course of treatment, but in some instances, a specialist is required for certain consultations. The NIH does not have the requisite support services and facilities for fertility preservation procedures, which has led to a Memorandum of Understanding (MOU) with the Walter Reed National Military Medical Center (WRNNMC). The contractor has a board-certified reproductive endocrinologist, cryopreservation equipment, monitoring, alarm system and maintenance to support collection and preservation of oocytes.

5. DEMONSTRATION THAT THE ANTICIPATED COST WILL BE FAIR AND REASONABLE

Based upon the prior acquisitions, the Cost in the past have been fair and reasonable for the scope of work.

6. DESCRIPTION OF MARKET RESEARCH CONDUCTED AND THE RESULTS OR STATEMENT OF

THE REASON MARKET RESEARCH WAS NOT CONDUCTED

Formal market research was not conducted because Shady Grove Fertility at Walter Reed is the current provider of the required testing services and maintains the Department’s historical data necessary for continuity of care and data integrity. Transitioning to another laboratory would require duplication of testing and revalidation of historical results, increasing Government costs and potentially impairing clinical care. Accordingly, continuation with the incumbent laboratory is necessary to ensure continuity and avoid duplication of effort and expense.

7. ANY OTHER FACTS SUPPORTING THE USE OF OTHER THAN FULL AND OPEN COMPETITION.

This is Sole Source as the current vendor has historical data that is relevant to this type of testing and protocol.

NIH Office of Purchasing and Contracts may provide market research to the extent it deems necessary.

8. LISTING OF SOURCES, IF ANY, THAT EXPRESSED, IN WRITING, AN INTEREST IN THE

ACQUISITION.

N/A

9. STATEMENT OF THE ACTIONS, IF ANY, THE AGENCY MAY TAKE TO REMOVE OR

OVERCOME ANY BARRIERS TO COMPETITION BEFORE ANY SUBSEQUENT ACQUISITION

FOR THE REQUIRED SUPPLIES OR SERVICES.

Due to the Proprietary Nature of the requirement, no actions can be taken to remove or overcome any barriers to competition.

10. ADMINISTRATIVE OFFICER/PROGRAM OFFICIAL CERTIFICATION

“I hereby certify that the information contained in this justification is accurate and complete to the best of my knowledge and belief.”

Sarah Polanco Administrative Officer

11. CONTRACTING OFFICER’S CERTIFICATION

“I hereby certify that the information contained in this justification is accurate and complete to the best of my knowledge and belief.”

Susan Nsangou Contracting Officer

Check Box3: Yes