S02_JandA_Q0408_allsigned___.pdf

Last Updated: 02/01/22

36C77024Q0408 – 760 CMOP

3-line Med/Surg

Acquisition Plans: 36C770-24-AP-0795 & 36C770-24-AP-0853 2237 numbers: 760-24-4-050-1337 & 760-24-4-050-1471

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

DEPARTMENT OF VETERANS AFFAIRS

BRAND NAME JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN

COMMERCIAL ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C770-24-AP-0795 & 36C770-24-AP-0853

Contracting Activity: The Department of Veterans Affairs, NCO 15 – CMOP Division - Contracting Office will be procuring four (4) medical surgical products; three (3) of which are brand name only items. Contracting office will utilize 2237 # 760-24-4-050-1337 & 760-

4-050-1471 for the replenishment of low stock levels at the (760) Leavenworth CMOP.

Nature and/or Description of the Action Being Processed: This procurement is for four medical surgical supplies (med/surg); three (3) being brand name only items. 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 proposed procurement action will be a new firm-fixed-price contract.

Description of Supplies/Services Required to Meet the Agency’s Needs: This is an individual brand name justification to support the procurement of the three (3) medical surgical items listed in the below table. Delivery will be a one-time delivery to the Leavenworth CMOP; ten (10) days after receipt of order.

Item Number CMOP IMFN Description

Local Stock Numbers/

MPNs QTY Unit of

Measure Packaging Multiple

Usage

Country of

Origin

OEM

NAME

Business

Size

VA CMOP

Leavenworth - 760 19927

RESERVOIR,T:SLIM X2

W/T:LOCK,3ML 10CT, XL551 89152-1180-05 4200 BX 10

Holds

Insulin Mexico Tandem Large

VA CMOP

Leavenworth - 762 18488

SET,INFUSION MINIMED

#MMT-381A

70524-4019-56

#MMT-381A 300 BX 10

Infusion Sets;

connects the

Insulin pump to the patients body. Mexico Medtronic Large

VA CMOP

Leavenworth - 763

21026 previoulsy

SET,INFUSION MINIMED

#MMT-386 10CT, XT791

05244-0017-82

#MMT-386 500 BX 10

Infusion Sets;

connects the

Insulin pump to the patients body. Mexico Medtronic Large

36C77024Q0408 – 760 CMOP

3-line Med/Surg

Acquisition Plans: 36C770-24-AP-0795 & 36C770-24-AP-0853 2237 numbers: 760-24-4-050-1337 & 760-24-4-050-1471

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

Last Updated: 02/01/22

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

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority):

Products have been prescribed for patients by VA physicians. Pharmacy employees do not have the training and/ or authority to countermand physician’s orders. “Brand Specific” products are the same thing as “dispense as written” on a physician’s prescription. No Manufacture Part Number (MPN) substitutions are permitted. In the VA, Pharmacy Benefits Management (PBM) has determined that CMOP IDs in the Manufacturer Part Number (MPN) will always identify “brand specific products in the “VA PRINT NAME” This is not always inclusive where a particular NDC 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 or work in coordination with brand name, medical surgical equipment.

o RESERVOIR,T:SLIM X2 W/T:LOCK,3ML 10CT, (89152-1180-05)

Acquisition Plans: 36C770-24-AP-0795 & 36C770-24-AP-0853 2237 numbers: 760-24-4-050-1337 & 760-24-4-050-1471

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

Last Updated: 02/01/22 o SET,INFUSION MINIMED #MMT-381A (70524-4019-56)

VHALEAKnighJ1 Highlight

Acquisition Plans: 36C770-24-AP-0795 & 36C770-24-AP-0853 2237 numbers: 760-24-4-050-1337 & 760-24-4-050-1471

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

Last Updated: 02/01/22 o SET, INFUSION MINIMED #MMT-386 10CT, (05244-0017-82)

Acquisition Plans: 36C770-24-AP-0795 & 36C770-24-AP-0853 2237 numbers: 760-24-4-050-1337 & 760-24-4-050-1471

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

Last Updated: 02/01/22

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: A sources sought notice was not posted for this acquisition because Med/Surge buys are routine, and the Contracting Officer is very knowledgeable about the Med/Surg marketplace. It is unlikely that a sources sought notice would produce significantly new information about the market. Therefore, a competitive solicitation will be posted to the Government point of entry at SAM.gov to provide public knowledge of VA’s requirement. Only qualified vendors will be able to submit quotes due to the Gray Market/Brand Name only, OEM requirements.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: Contracting Officer anticipates cost of award will be fair and reasonable based on competition, the Independent Cost Government Estimate (IGCE), and previous acquisition cost history for the same requirements.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: In accordance with FAR Part 10 and VAAR 810 market research was conducted. Market research is being conducted on 8/29/2024 for the upcoming acquisition of four med/surg items.

A sources sought notice was not posted for this acquisition because pharmaceutical/ Medical Surgical buys are routine, and the Contracting Officer is very knowledgeable about the pharmaceutical/ Medical Surgical marketplace. It is unlikely that a sources sought notice would produce significantly new information about the market. Therefore, a competitive solicitation will be posted to the Government point of entry at SAM.gov to provide public knowledge of VA’s requirement.

Market research confirmed that these med/surg products are not available from typical contract vehicles or supply chains. All avenues have been exhausted by CMOP via searches on Prime Vendor, NAC and FSS; an open market procurement is the only option that remains for purchasing these med/surg products.

The Contracting Officer conducted further searches in VetCert utilizing NAICS code:

325413, In-Vitro Diagnostic Substance Manufacturing and yielded a total of 90 SD/VOSBs who identified as authorized distributors. Further market research was conducted via Dynamic Small Business search (DSBS) which resulted in 19 small businesses who identified as authorized distributors.

36C77024Q0408 – 760 CMOP

3-line Med/Surg

Acquisition Plans: 36C770-24-AP-0795 & 36C770-24-AP-0853 2237 numbers: 760-24-4-050-1337 & 760-24-4-050-1471

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

A query was conducted via the National Institutes of Health (NIH) U.S. National Library of Medicine DailyMed website. The purpose of this search is to determine if there are any domestic sources available (both large and small business concerns) in the marketplace. The items were searched, and no results were found.

The CMOP Medication Image Library along with the manufacturer’s website was searched, the chart below shows the manufacturer, business size, usage and country of origin for each med/surg product.

The Nonmanufacturer Rule –

The Contracting Officer reviewed the Non-Manufacturer Rule. In accordance with the Non- Manufacturer Rule as defined in 13 CFR 121.406(b), there are two or more small business concerns who identify themselves as authorized distributors. These small businesses have 500 or less employees, engage in the retail wholesale trade and normally sell pharmaceuticals, take ownership or possession of the pharmaceutical via its facilities or via its personnel. However, market research concludes that there are presently no small business manufacturers that exist in the commercial marketplace. The CO has confirmed there is no class waiver associated for Medical Surgical Supplies under NAICS Code 325413. The Contracting Officer considered the use of an individual waiver, however, is not feasible due to the expedient nature of this acquisition. A small business set-aside is not feasible as a small business would not be able to comply with the NMR since there are presently no small business manufacturers.

Item Number Description

Local Stock Numbers/

MPNs Usage Country of

Origin

OEM

NAME

Business

Size

RESERVOIR,T:SLIM X2

W/T:LOCK,3ML 10CT, XL551 89152-1180-05 Holds Insulin Mexico Tandem Large

SET,INFUSION MINIMED

#MMT-381A

70524-4019-56

#MMT-381A

Infusion Sets;

Connects the Insulin pump device to patients body Mexico Medtronic Large

SET,INFUSION MINIMED

#MMT-386 10CT, XT791

05244-0017-82

#MMT-386

Infusion Sets;

Connects the Insulin pump device to patients body Mexico Medtronic Large

Acquisition Plans: 36C770-24-AP-0795 & 36C770-24-AP-0853 2237 numbers: 760-24-4-050-1337 & 760-24-4-050-1471

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

Last Updated: 02/01/22

Discuss consideration to BAATAA/Exception to BAA (See FAR Part 25) Three of the items (Line Items 1, 3, & 4 are Brand Name only products. Per FAR 25.01(a)(5) the use of the sole source justification for brand name only - is an exception to the use of trade agreements. Furthermore, the total value of the three-brand name items values 83% of the total procurement. Therefore, BAA applies. The three brand name items are all made in Mexico and require a BAA wavier. A pre-RFQ waiver will be submitted.

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

Previous acquisition history with this VA contracting office has shown a mix of large and small businesses have met and fulfilled this product in the recent past.

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

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 MPN 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.

Jennifer Knight Contract Specialist Network Contracting Office 15 – CMOP Division

Jennifer Knight

Digitally signed by Jennifer Knight Date: 2024.09.03 10:31:20 -05'00'

Acquisition Plans: 36C770-24-AP-0795 & 36C770-24-AP-0853 2237 numbers: 760-24-4-050-1337 & 760-24-4-050-1471

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

Diane Nolting Logistics Manager Leavenworth CMOP

14. 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.

Kelley Cunningham Contracting Officer Network Contracting Office 15 – CMOP Division

J. Braden Smith Branch/Division Chief Network Contracting Office 15 – CMOP Division

DIANE NOLTING

Digitally signed by DIANE

NOLTING

Date: 2024.09.03 14:36:20 -05'00'

KELLEY

CUNNINGHAM

Digitally signed by

KELLEY CUNNINGHAM

Date: 2024.09.04 07:15:14 -05'00'

JUSTIN SMITH Digitally signed by JUSTIN SMITH Date: 2024.09.04 08:57:39 -05'00'