6515-- 763-22-2-021-0595- Sole Source-Atos Medical Inc. -Med/Surge 9 line items, 6-months ARO, 04/04/2022 - 10/03/2022.

VHAPG Part 813.5 Simplified Acquisition Procedures for Certain Commercial Items

Page 1 of 4

Attachment 1: Request for Sole Source Justification Template >SAT-$7.5M under FAR13.5

DEPARTMENT OF VETERANS AFFAIRS

SOLESOURCEJUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C770-22-AP-0369

Contracting Activity: Department of Veterans Affairs, NCO 15, National CMOP Contracting Office. 2237 # 763-22-2-021-0595, Leavenworth CMOP, Leavenworth, KS.

Nature and/or Description of the Action Being Processed: This procurement is for medical surgical supplies (med/surg) in accordance with FAR13.5 Simplified Procedures for certain commercial items and specifically FAR13.501Special 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 proposed procurement action will be a new firm-fixed-price contract in support of 763 CMOP located in Lancaster, TX.

Description of Supplies/Services Required to Meet the Agency's Needs: This is an individual brand name justification to support the procurement of nine (9) medical surgical items listed below in the following table. The estimated value of the required MedSurg supply is $- All item quantities will be delivered over a six (6) month schedule in increments equaling one-sixth of total quantity per item per month as shown below, after receipt of order. For example, item 0001 will be shipped in quantity of 100 per month for six months to achieve 600 total quantity ordered.

Item

Number

Description

Quantity

Unit of

Packaging

Unit

Price-

Measure

Multiple

0001

PROVOX, Heat& Moisture Exchanger

XR205

600

BX

30

-

0002

PROVOX, Heat& Moisture Exchanger

XK656

240

BX

30

-

0003

PROVOX, Heat& Moisture Exchanger

480

BX

30

-

0004

PROVOX, Heat& Moisture Exchanger

XK657

240

BX

30

-

0005

PROVOX, Trach

Baseplate Adhesive XH056

360

BX

15

-

0006

PROVOX, Heat& Moisture Exchanger

XK649

180

BX

15

-

-

Attachment 1: Request for Sole Source Justification Template >SAT-$7.5M under FAR13.5

0007

PROVOX, Heat& Moisture Exchanger

XK658

180

BX

30

0008

PROVOX, Trach Baseplate Adhesive

XK767

180

BX

30

-

0009

PROVOX, Trach Baseplate Adhesive

XK768

180

BX

30

-

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 FAR13.5 is 41 U.S.C. § 1901 and is implemented by FAR13.106-1(b)(2) for restricting competition on this procurement. Competition is restricted on thisprocurement 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

Demonstration that the Contractor's Unique Qualificationsor Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): Provox products have been prescribed for patients by VA Physicians. Pharmacy employees do not have the training and/or authority to countermand physician orders. "Brand Specific" products are the same thing as "dispense as written" on a physician's prescription. No National Drug Code (NOC) substitutions are permitted. In the VA, Pharmacy Benefits Management (PBM) has determined that CMOP IDs in the National Drug File (NDF) will most always identify "brand specific" products in the "VA PRINT

NAME." This is not always inclusive where a particular NOC has been determined to be "formulation specific" by clinical evaluation performed by the PBM or in the case where only one product in the marketplace has been identified to contain the specific ingredients to match the product code.

Contract Specialist (CS) Gerald Bingham has determined that this requirement will be sole sourced to Atos Medical Inc., the manufacturer of PROVOX brand for highly specialized medical equipment with no authorized distributors for their products. Atos Medical is headquartered in Sweden and has a subsidiary office in Wisconsin, United States.

Accordingly, Atos Medical Corporation is the only firm available of providing the supplies described in Section 3 to fulfill requirement in accordance with (IAW) FAR 6.302-1 "Only one responsible source and no other supplies or services will satisfy agency requirements."

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

Page 3 of 4

Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: Competition not available (IAW) FAR 6.302-1 "Only one responsible source and no other supplies or services will satisfy agency requirements."

Determination by the CO that the Anticipated Cost to the Government will beFair and Reasonable: The anticipated cost will be fair and reasonable based off requirement owner's IGCE. Contracting Officer may request price and cost certification per FAR15.403-4(a)(2) and (b)(l) to determine fair and reasonable pricing.

Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: Non-manufacturer requirements apply and the VIP database search concluded there are no known SDVOSB or VOSS manufacturers of the above referenced brand name MedSurg item for NAICScode 325413. Therefore, the "Rule of Two" cannot be met and a SDVOSB set-aside is not feasible. Furthermore, in accordance with FAR Part 25.401(a) (5), the Buy American Act (BAA), BAA application procedures the do not apply to the price factors of this solicitation.

Any Other Facts Supporting the Use of Other than Full and Open Competition: This will be a sole source award to a small business.

Listing of Sources that Expressed, in Writing. an Interest in the Acquisition: Sources Sought Inquiry not posted to SAM.gov for this requirement due to only one available source available from manufacture having no authorized distributorships for Brand Name PROVOX medical supplies.

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 action is being taken at this time due to the fact that no NDC substitutions are permitted based on physician's specific orders.

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.

Todd R.

Digitally signed by Todd R. Swank 712065

Swank 712065; 022.03.1114:12:21

Todd Swank

Deputy Logistics Manager 763 CMOP, Lancaster, TX

See Digital Signature Date

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.

Prepared by:

GERALD BINGHAM

Gerald Bingham Contract Specialist

Digitally signed by GERALD BINGHAM Date: 2022.03.11

10:45:55 -06'00'

See Digital Signature Date

National CMOP Contracting Office (NCO 15)

Approved by:

JUSTIN SMITH

J. Braden Smith

Digitally signed by JUSTIN SMITH Date: 2022.03.14

07:04:17 -05'00'

See Digital Signature Date

Contracting Officer

National CMOP Contracting Office (NCO 15)

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.

Dufour, Benjamin

Division Chief of Contracting (DCOC) NCO 15 CMOP Office

See Digital Signature Date Awarded contract 36C77022P0270 to ATOS MEDICAL INC. for 310335.00000000 on 2022-04-11.