P03 Sole Source Justification - SAT-7.5M Hologic Signed.pdf

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

Effective Date: 11/15/24 Page 1 of 4

REVISION: 01

Acquisition ID#: 36C263-26-AP-0100

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C263-26-AP-0100

1. Contracting Activity:

Department of Veterans Affairs, Network Contracting Office NCO23, located at 1303 5th St, STE 300, Coralville, IA 52241, in support of Iowa City VA Health Care System.

2. Nature and/or Description of the Action Being Processed:

This procurement is for reagents and assay kits for the laboratory’s Panther system in accordance with FAR 13.5 Simplified Procedures for Certain Commercial Items and specifically FAR 13.501 Special Documentation requirements, where acquisitions conducted under Simplified Acquisition Procedures are exempt from the requirements of FAR part 6 but still require a justification using the format of FAR 6.303-2. The action will be awarded as a new firm fixed price, four year IDIQ with four one-year ordering periods.

3. Description of Supplies/Services Required to Meet the Agency’s Needs:

These supplies are needed by the Iowa City VA HCS laboratory in order to perform immunological testing on veteran samples. The supplies needed are for the Panther system made by Hologic. With zero distributors, Hologic is the only source able to provide these supplies.

Anticipated period of performance:

Ordering Period 1: 10/01/2025 – 09/30/2026 - $157.880.00 Ordering Period 2: 10/01/2026 – 09/30/2027 – $157.880.00 Ordering Period 3: 10/01/2027 – 09/30/2028 – $157.880.00 Ordering Period 4: 10/01/2028 – 09/30/2029 – $157.880.00

Total Value/Cielling: $631,520.00

4. Statutory Authority Permitting Restricted Competition:

FAR 13.5 Simplified Procedures for Certain Commercial Items. The statutory authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. § 1901 and is 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

Effective Date: 11/15/24 Page 2 of 4

( ) 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):

The continued acquisition of reagents and assay kits for the Panther system is critical to the healthcare of veterans. It allows for the testing of HPV, HPV16 18/45, COVID19, HIV, and HCV by the Iowa City VA HCS Immunology Department of Pathology.

Hologic is the original equipment manufacturer of the Hologic Panther System as well as the reagents and assay kits used by the instrument. They currently have zero distributors nor does the instrument allow for any substitutions. As demonstrated in the Market Research Findings, Hologic Sales and Service, LLC is the only vendor able to provide these supplies.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable:

Market research, including a notice of intent to sole source posting on Contract Opportunities for seven days, yielded no responses from alternative vendors capable of meeting this requirement.

Hologic Sales and Service, LLC remains the only known source able to provide the needed reagents and assay kits for the Panther System.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable:

This requirement will be fair and reasonable based on its previously awarded prices in accordance with FAR 13.106-3(a)(2)(ii) Comparison of the proposed price with prices found reasonable on previous purchases such as Contract 36C25923A0028 which was awarded by the Denver VAMC.

Although, these contracts weren’t exactly the same, both contracts included many matching Line Items that demonstrated Iowa City VAHCS is receiving lower prices for the same products.

Furthermore, FAR 13.106-3(a)(2)(vi) Comparison to an independent government estimate was also used to determine if prices were fair and reasonable to the government and the comparison showed that the prices quoted by the Hologic were $28,200.00 lower than the IGCE a 16.3% difference.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons

Market Research Was Not Conducted:

a. Conducted a search on the GSA eLibrary for Items: “hologic” which garnered zero (0) results on the GSA website.

Effective Date: 11/15/24 Page 3 of 4

b. Conducted a search on the NAC for Items: “Aptima” which garnered zero (0) results on the NAC website.

c. Conducted a search on Federal Procurement Database Systems (FPDS) using keywords: “NAICS Code:” 334516” DEPARTMENT_FULL_NAME: ”VETERANS AFFAIRS,DEPARTMENT OF” and produced 86,864 results showing contracts awarded by the Department of Veterans Affairs.

Conducted a search on Federal Procurement Database Systems (FPDS) using keywords: “UEI:

”Q1NBY5GKN9Z3” DEPARTMENT_FULL_NAME: ”VETERANS AFFAIRS,DEPARTMENT OF” and produced 2,232 results showing contracts awarded by the Department of Veterans Affairs to Hologic Sales and Service, LLC.

d. Conducted a search on DSBS SBA using NAICS Code: 334516. The search listed 492 SBA certified 8(a) or 8(a) JV, HUBZone, WOSB, EDWOSB, VOSB or VOSB JV, or SDVOSB or SDVOSB JV, and designated small in NAICS code(s) 334516.

e. Notice of Intent to Sole Source was posted to Contract Opportunities on 06/10/2025 with responses due on 06/17/2025. The posting garnered zero (0) responses.

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

The Hologic Panther System used to perform this testing is currently owned by the Iowa City VA HCS. The reagents used are proprietary to this instrument and makes it impossible to compete.

Seeking out new equipment before the end of the equipment’s lifecycle would be a huge loss to the Department of Veterans Affairs.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition:

Hologic Sales and Service, LLC

SAM: Q1NBY5GKN9Z3

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:

It is unlikely that another vendor will be allowed to distribute or make a substitute for these reagents in the foreseeable future. However, the VA will continue to monitor the market for any additional vendors for future acquisitions of this nature.

Effective Date: 11/15/24 Page 4 of 4

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.

Kathleen Bain Date Administrative Officer Iowa City VA Health Care System

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

a. Contracting Officer or Designee’s Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Steve Ashby Date Contract Officer Network Contracting Office 23 / Service Supply Team 2

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.

Curt LaRose Date Branch Chief Network Contracting Office 23 / Service Supply Team 2 https://dvagov.sharepoint.com/sites/VHAProcurement/VHAPM/VHAPM_Part_806.3.aspx