36C25618Q0128-002.pdf

VHAPM Part 806.3 Other Than Full and Open Competition (OFOC) SOP Attachment 2: Request for Sole Source Justification Format aragE

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A)

For

Other Than Full and Open Competition IMMO

Acquisition Plan Action ID: VA256-18-AP-0476 — Vascular Surgical Packages

1. Contracting Activity: Department of Veterans Affairs, VISN 16, Alexandria VA Healthcare System, Pineville, LA. Purchase Request/2237 transaction # 520-18-1-131-0003.

2. Nature and/or Description of the Action Being Processed: Purchase of various disposable Boston Scientific Vascular Surgical Packs to be used with Boston Scientific stints/implants during surgical procedures. The action will be awarded as a new firmed fixed price purchase order.

FAR13.5 Simplified Procedures for Certain Commercial Items: This procurement is for the purchase of Vascular Surgical Packs 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.

3. Description of Supplies/Services Required to Meet the Agency's Needs: The supplies are surgical/diagnostic devices in surgical packs that are used in conjunction with Boston Scientific implants. The Gulf Coast Veterans Healthcare System (GCVHS), Biloxi, MS require an initial inventory stock of these packs in order to perform surgical implant procedures. The initial inventory stock of packs are estimated at 121 individual packs The estimated delivery date is 10 calendars afters receipt of purchase order.

4. Statutory Authority Permitting Other than Full and Open Competition: 41 USC §3304(a)(1), as implemented by FAR 6.302-1.

(X) (1) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements per FAR 6.302-1;

( ) (2) Unusual and Compelling Urgency per FAR 6.302-2;

( ) (3) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services per FAR 6.302-3;

( ) (4) International Agreement per FAR 6.302-4 ( ) (5) Authorized or Required by Statute FAR 6.302-5;

( ) (6) National Security per FAR 6.302-6;

( ) (7) Public Interest per FAR 6.302-7;

FAR13.5 Simplified Procedures for Certain Commercial Items: The authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. 1901 and is implemented by for restricting competition on this procurement via FAR 13.106-1(b)(2) or 13.501(a)(2)(i).

OFOC SOP Revision 06 Page 1 of 3 Original Date: 03/22/11 Revision 06 Date: 08/30/2017

Attachment 2: Request for Sole Source Justification Format .

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 requirement for Vascular Surgical Packs products is restricted to the Boston Scientific Corporation brand name. The GCVHSS, Biloxi, Ms currently uses the Boston Scientific stints/implants during surgical procedures. The Boston Scientific packs are engineered to be used in conjunction with Boston Scientific implants. For optimal clinical safety outcomes, these packs are the only products that can be used with the implants. The use of the Boston Scientific Vascular Surgical Packs is essential to ensure standardization with existing implants, reduce the possibility of error, and thereby increase the safety and care of patients. Furthermore, the GCVHCS has purchased oston Scientific implants. Failure to use the proper packs associated with the existing implants in stock will result in a substantial duplication of cost.

Boston Scientific Corporation is the sole manufacturer of the Vascular Surgical Packs. The only authorized distributor is Veterans Healthcare Supply Solution Inc. (VHSS Inc.), a service-disabled veteran owned small business (SDVOSB). VHSS, Inc. is the only SDVOSB firm capable of providing the surgical packs without the VAMC experiencing substantial duplication of cost.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: As part of the market research, the manufacturer was contacted directly to confirm the availability of authorized distributors of the brand name product. In accordance with FAR 6.302-5(a)(2)(ii) a source sought synopsis was not required due to the fact only one SDVOSB authorized distributor was identified. However, an RFQ with restriction to SDVOSBs and brand name (Boston Scientific part numbers for surgical packs) will be issued on Federal Business Opportunity to ensure full and open competition to the maximum extent practical.

No other action taken or planned to facilitate competition fOr th-1 cquisition,

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: The anticipated cost will be compared to similar products from other manufacturers for same or similar items. Furthermore, a RFQ will be issued on FB0 with restriction to SDVOSB under NA/CS 339112. The requirements is valued at OM Therefore certified cost and pricing data is not required.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: Although market research indicate the specific Boston Scientific brand is only manufactured by Boston Scientific Corporation with only one authorized distributor, a search of VETBIZ show there are at least two or more "verified" SDVOSB with the NA/CS 339112. Therefore a RFQ will be issued on FBO with restriction to SDVOSB and the brand name part numbers specified.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: Not Applicable.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: Not Applicable.

OFOC SOP Revision 06 Page 2 of 3 Original Date: 03/22/11

Attachment 2: Request for Sole Source Justification Format

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 planned at this time to remove or overcome barriers to competition. This is due in part to the fact, the medical hos oston Scientific implants in stock.

12. Requirements Certification: I certify that the requirement outlined in this justification is atTona #

:Ficfel\Wed of the Deprtrpent of Veterans Affairs and that the supporting data under my cognizance, which are included it9tI just. ion, are accurate and complete to the best of my knowledge and belief.

Martin T. Krecker, MD Date Chief Surgery Service

Gulf Coast Veterans Healthcare 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.

Digitally signed by LONEST BONTON

LON EST

182209 DN: dc=gov, dc=va, o=internal, ou=people, BONTON 18220Lag,), 0.9.2342.19200300.100.1.1=lonest.bonton@ cn=LONEST BONTON 187709

Lonest Bonton Date: 2017.11.1407:59:58

Contracting Officer

NCO 16, Alexandria VAHCS

b. One Level Above the Contractin Officer certify the justification meets requirements for other than full and open competition.

Digitally signed by Renata Ott 659452

DN dc-•gov, dc=va. o=internal, ou=people, Renata Ott 6594-52 0.9.2342.19200300.100.1.1=renata.ott4va.gov, cn=Renata

Ott 659452

Date 2017.1i .14 07.5347 -0600'

Renata Ott

Branch Chief, DIV II —Supply Team C Date

Network Contracting Office 16

Alexandria VAHCS

OFOC SOP Revision 06

Original Date: 03/22/11