P03 Sole Source Justification over SAT Germfree Pharmacy Compounding Trailer 9 April 2024_REDACTED_Redacted.pdf

VHAPG Part 813.5 Simplified Acquisition Procedures for Certain Commercial Items Attachment 1: Request for Sole Source Justification >SAT $7.5M under FAR13.5

Effective Date: 02/01/2022 Page 3 of 5 implemented by FAR 13.106-1(b)(2) for restricting competition on this procurement. Competition is restricted on this procurement for the reason below:

(x) Only One Responsible Source and No Other Supplies or Services Will Satisfy

Agency Requirements ( ) Unusual and Compelling Urgency ( ) Industrial Mobilization, Engineering, Developmental or Research Capability or

Expert Services ( ) International Agreement ( ) Authorized or Required by Statute ( ) National Security ( ) Public Interest

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the

Acquisition Requires the Use of the Authority Cited Above (applicability of authority): As described in the Market Research Report, Germfree Laboratories, LLC is the only authorized service provider for Germfree equipment in the United States.

The risk of not awarding this contract will have an impact on the operational status of the items listed under paragraph 3 of this document. In addition, only certified personnel shall perform services on this equipment; otherwise, warranties may be voided. The pharmacy trailer is a highly specialized and custom built equipment to support VACHS Pharmacy Department mission and responsibilities towards veterans.

It is essential to award this requirement in a sole-source basis to Germfree Laboratories, LLC to ensure that the unit continuous running optimally and compliant with USP 797/800. Otherwise, the VACHS Pharmacy Department may be seriously affected and hindered.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: Competition for this requirement is not possible since Germfree Laboratories, LLC as the manufacturer of highly specialized trailers has not authorized any reseller or service provider to perform maintenance and repair to the equipment they manufacture. A search on the SBA VetCert website revealed that there are no SDVOSB nor VOSB that can fulfill this requirement. A sources sought notice is not needed at this time since there is enough evidence that this is the only company that can fulfill this requirement.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: This acquisition will be conducted under FAR 13.501(a).

Since there will be no competition, the vendor may be required to provide evidence of catalog prices and or other sales receipts to other customers to validate that the final prices are fair and reasonable. In addition, proposed prices may be compared with other purchases previously made by another VA Medical Centers/NCOs offices.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: The market research demonstrated that only Germfree Laboratories, LLC is the sole service provider for Germfree equipment in the United States. Germfree is considered other than small

Effective Date: 02/01/2022 Page 4 of 5 business located in Ormond Beach, Florida, with a local office in Dorado, Puerto Rico.

As described in Section 6 above, market research, in accordance with FAR Part 10, was conducted by synopsis of the proposed acquisition, advising industry of the pending acquisition, and soliciting inquiries from interested parties.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition:

As documented in the market research, open competition is not feasible since Germfree Laboratories is the only service provider for their own equipment.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: No other source, other than Germfree Laboratories has expressed interest in this requirement.

11. A Statement of the Actions, if any, the Agency May Take to Remove or

Overcome any Barriers to Competition before Making subsequent acquisitions for the supplies or services required: In order to foster competition, the government will need to buy/replace existing pharmacy trailer, which may cost millions and which are not budgeted at this time and the government may end up in a similar sole-source position when procuring preventive maintenance services. Therefore, the best course of action is to award this requirement to Germfree Laboratories, LLC.

12. Requirements Certification: I certify that the requirement outlined in this justification is a Bona Fide Need of the Department of Veterans Affairs and that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief.

13. Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

a. Contracting Officer: I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Effective Date: 02/01/2022 Page 5 of 5

b. One Level Above the Contracting Officer (Required over SAT but not exceeding $750K): I certify the justification meets requirements for other than full and open competition.