J_A Hologic Panther Reagents.pdf

Part 806.3 Other Than Full and Open Competition (OFOC) Attachment 7: Request for Sole Source Justification Format >SAT

Rev: 12 Effective Date: 02/01/22 Page 1 of 3

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: 36C246-22-AP-5705

1. Contracting Activity: Department of Veterans Affairs, Network Contracting Office 06, Hampton, VA located at 100 Emanicpation Drive, Hamption VA 23667.

Purchase Order: 590-23-1-023-0029

2. Nature and/or Description of the Action Being Processed: The Hampton VA Medical Center has a requirement for an Indefinite Quantity Contract with Hologic, Inc for reagents, standards, controls, supplies, disposables and equipment repair and preventative maintenance for for the Hologic Panther System.

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

Hampton VA Medical Center has a requirement for the vendor to provide a continuously stocked inventory of reagents, standards, controls, supplies, disposables and any other materials required to properly perform tests on the Panther System in such a way that the operations are not interrupted.

The government also requires the vendor to provide technical assistance/support center by telephone 24 hours per day, 7 days per week with a maximum call back time of four (4) hours for Premium. If chosen Standard will provide technical assistance/support center by telephone Monday-Friday 5:00 am – 5:00 pm with a maximum call back response of one (1) hour at no additional charge. Field Engineering Services and Training will be provided on a time scale as well.

4. Statutory Authority Permitting Other than Full and Open Competition: .

( X ) (1) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements per 41 USC §3304(a)(1) as implemented by FAR 6.302-1;

( ) (2) Unusual and Compelling Urgency per 41 USC §3304(a)(2) as implemented by FAR 6.302-2;

( ) (3) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services per 41 USC §3304(a)(3) as implemented by FAR 6.302-3;

( ) (4) International Agreement per 41 USC §3304(a)(4) as implemented by FAR 6.302-4 ( ) (5) Authorized or Required by Statute per 41 USC §3304(a)(5) as implemented by FAR 6.302-5;

( ) (6) National Security per 41 USC §3304(a)(6) as implemented by FAR 6.302-6;

( ) (7) Public Interest per 41 USC §3304(a)(7) as implemented by FAR 6.302-7;

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): Hologic has provided a sole source letter verifying as manufacturer they are the sole provider of the needed supplies and services for the Panther System.

Effective Date: 02/01/22 Page 2 of 3

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: This is a manufacturer only provided product and service per provided verification letter after request for list of distribution partners.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: The anticipated cost to the government will be fair and reasonable based on the cost paid for the past twelve months and the expense saved in not replacing the Panther System in an effort to use another system. The cost can be compared to similar systems that run similar tests without running them in a continuous manner thus adding staff time for loading and reloading the machine.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: Market Researchwas conducted pursuant to FAR Part 10, VA Acquisition Regulation (VAAR) 810.001-70 Market Research Policy, and PPM 2016-05(Revised Aug 2019). The Rule of Two could not be met as no SDVOSB /VOSB vendors were located that could fulfill the governments needs. The government will continue to conduct market research to ascertain if there are changes in the marketplace that would enable future actions to be competed; such as the manufacturers allowance of distributors or resellers in the future.

• Search of Vetbiz using NAICS Code 325413 (In-Vitro Diagnostic Substance Manufacturing), keyword “Hologic” revealed zero SDVOSB/VOSB concerns.

• Search of both GSA Advantage and GSA e-Library revealed zero results.

• Search of NAC, SAC, NASA SEWP, MSPV-NG, VA Ability One and NX Equipment Catalog using revealed zero results.

• Search of SBA -DSBS revealed zero results.

• Search of FDPS using keyword “Hologic Panther “revealed (FY 22 Acqusitisions): 2 Blanket

Purchase Agreements, 2 Definitive Contracts, 3 Indentfinite Delivery Contracts, 7 Delivery Orders, and 6 Purchase Orders

• Further market research was conducted by contacting the OME (Hologoc Inc.) directly, who provided a sole source letter verifying that the Hologic Inc. is the sole proprietary manufacturer and domestic distributor of the Panther System reagents and consumable supplies needed to operate the analyzer.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: No additional facts are necessary or available.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: No additional sources expressed an interest in the acquisition.

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: No actions are available to remove or overcome barriers to competition unless equipment purchased in 2020 is replaced.

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.

https://www.acquisition.gov/?q=/browse/far/10 https://www.va.gov/oal/library/vaar/vaar810.asp

Effective Date: 02/01/22 Page 3 of 3

Mary Petty Date Laboratory Manager Hampton VA Medical Center

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.

James Risbon Date Contracting Officer

NCO 06

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.

Jerry Mann Date Branch Chief, NCO 06 https://dvagov.sharepoint.com/sites/VHAProcurement/VHAPM/VHAPM_Part_806.3.aspx