JOFOC Hologic Mammography System PM.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: 02/01/2022 Page 1 of 4

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C261‐24‐AP‐5443 Justification Other Than Full and Open Competition (JOFOC) Log Number: FY25‐NCO 21‐69

1. Contracting Activity: Department of Veterans Affairs, Veterans Integrated Service Network (VISN)

21, Network Contracting Office (NCO) NCO 21, 3237 Peacekeeper Way, Building 200, Suite 204, McClellan, CA 95652 on behalf of VA Sierra Nevada Health Care System (VASNHCS).

VA 2237: 593‐25‐1‐141‐0008

2. Nature and/or Description of the Action Being Processed: The Department of Veterans Affairs proposes to enter into a firm‐fixed‐price contract on the basis of other than full and open competition with Hologic, Inc. (Hologic). This procurement is for preventative maintenance of VASNHCS’ Hologic Mammography 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.

This request is to establish a new contract to replace Contract 36C26123P1012. This contract provided preventative maintenance and software updates for Hologic Mammography System for VASNHCS. This contract was awarded to Hologic, Inc. on a sole source basis on 5/09/2023. The contract provided services from 5/10/2023 through 5/09/2024.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: This contract will consist of a 12‐month base year, with four one‐year options. The services for this contract will be performed from 11/01/2024 through 10/31/2029. The estimated cost of the base year is

, and the estimated total contract value is .

The requested preventative maintenance services include software updates, unlimited technical services, clinical application, telephone support, and remote services. The Hologic Mammography System is critical to VASNHCS’ overall ability to provide Veteran care. Hologic is to provide preventative services to the following equipment items:

Equipment Description Model Serial Number

Hologic Dimensions Tomo SDA‐SYS‐3000‐3D SDM131901997

Hologic Dimensions Tomo SDA‐SYS‐3000‐3D SDM131902013

Breast Biopsy System Affirm 82991120217

SecurView DX‐400 2980312B4143

Horizon W No Model 306129M

ATEC Sapphire Biopsy System No model 201094

SecurView DX‐1200 9780822D1163

SecurView Manager Hi Res 2960722D0390

Effective Date: 02/01/2022 Page 2 of 4

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 ( ) 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 procurement is a sole source to Hologic, Inc., 250 Campus Dr., Marlborough, MA 01752. There are no other sources of supply/service that will satisfy agency requirements. The Hologic Mammography system is in use and maintained by Hologic, Inc.

The services requested are proprietary and can only be provided by Hologic trained service engineers who only work on Hologic products. Hologic does not authorize any third‐party service providers to provide the requested service for these products.

Hologic is the only firm capable of providing the supplies and services without the Veterans Health Administration experiencing substantial duplication of cost that could not be expected to be recovered through competition.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: Intent to Sole Source Synopsis 36C26124Q0990 was published to SAM.GOV on 08/28/2024 and closed on 09/06/2024. One response was received from The Remi Group, LLC.

The Remi Group LLC. provided their capability statement and completed the questionnaire attached to the sole source notice. Their response was sent to the station’s subject matter expert (SME) for review. The SME determined this vendor is not a service provider but rather a management company that maintains records, coordinates scheduled service, and handles inspections and regulatory agencies. Furthermore, the Contracting Officer (CO) received email correspondence from Hologic stating, they do not approve of any 3rd party service providers to service their equipment.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: The CO will review and determine if the anticipated price is considered fair and reasonable. FAR Part 13 Open Market Decision Documentation Form shall detail how the Government will determine that the anticipated cost is fair and reasonable. The basis of price reasonableness will be determined based on comparison with similar items in the related industry.

Effective Date: 02/01/2022 Page 3 of 4

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: As describe 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. Through market research, the CO has determined that Hologic does not have any authorized third‐party service providers for preventative maintenance on the Mammography System. The VetCert database was searched using North American Industry Classification System (NAICS) 811210. The search resulted in 308 SDVOSB/VOSB vendors. However, due to the proprietary nature of this requirement, it must be awarded on a sole source basis to Hologic, Inc.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: There are no other facts.

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

The Remi Group, LLC Hologic, Inc.

6325 Ardrey Kell Road, Suite 200 250 Campus Dr.

Charlotte, NC 28277 Marlborough, MA 01752

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: Hologic is the only source that can perform preventative maintenance on the Mammography System due to the proprietary nature of the equipment. Hologic does not authorize any third‐party service providers to provide the requested services. The Department of Veterans Affairs will continue to monitor the commercial marketplace to determine if other sources are responsible and capable of providing this type of service that meets the needs of VISN 21.

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.

Robert Herndon Date Biomedical Equipment Support Specialist VAMC Southern Nevada Healthcare System

9/24/2024ROBERT HERNDON

Digitally signed by ROBERT

HERNDON

Date: 2024.09.24 14:24:18 -07'00'

Effective Date: 02/01/2022 Page 4 of 4

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.

Tim Smith Date Contracting Officer, Services III

Network Contracting Office 21

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.

Nicholas Kluch Date Director of Contracting

Network Contracting Office 21

c. VHA RPO HCA Review and Approval: I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and approve ($750K to $7.5 million (or $15.0 million for acquisitions described in FAR 13.500(c)) for other than full and open competition.

Curtis M. Jordan Date Executive Director, Regional Procurement Office West VHA Head of Contracting Activity (HCA)

TIMOTH

Y SMITH

Digitally signed by

TIMOTHY SMITH

Date: 2024.09.24 14:41:51 -07'00'

NICHOLAS KLUCH Digitally signed by NICHOLAS KLUCH Date: 2024.09.25 12:01:14 -07'00'

CURTIS

JORDAN

Digitally signed by CURTIS

JORDAN

Date: 2024.09.25 18:58:45 -06'00'