P03_Justification and Approvals_OVER 250K_760-24-1-050-0243_Redacted.pdf

VHAPM Part 813.5 Simplified Acquisition Procedures for Certain Commercial Items Attachment 1: Request for BRAND NAME Justification Template >SAT-$7.5M under FAR13.5

Effective Date: 02/01/2022

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-0138 (760-24-1-050-0243)

1. Contracting Activity:

Network Contracting Office 15 (NCO 15) - CMOP Division 3450 S. 4th St. Trafficway Leavenworth, KS 66048-5581

Requesting Activity:

VA CMOP Leavenworth 5000 S. 13th St.

Leavenworth, KS 66048-5580

PR-IFCAP (2237): 760-24-1-050-0243

2. Nature and/or Description of the Action Being Processed:

This procurement is for BRAND NAME supplies as requested by the VA Medical Centers from the VA CMOP LEAVENWORTH 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.

PR-IFCAP: 760-24-1-050-0243

ACTION REQUESTED: 1 (New Requirement) Action will be awarded as a new contract, firm-fixed-price.

This Justification & Approval (J&A) is a class J&A authorizing Other Than Full and Open Competition

CLASSIFICATION CODE: 65 (MEDICAL EQUIPMENT)

CONTRACT TYPE: 1 (Commodities) Purchase of: MedSurg.

Description: "Multiple" PROCUREMENT METHOD: Total Set-Aside PROCUREMENT VEHICLE: Open Market SOCIOECONOMIC CATEGORY: Service Disabled Veteran Owned SB PURCHASING SCOPE: 1 (Single Site)

Est. Award Date: 12-22-2023 Est. Comp. Date: 01-09-2024

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

BRAND NAME supplies as requested by the VA Medical Centers from the VA CMOP LEAVENWORTH Drug Name: "Multiple"

MedSurg supplies have been prescribed for patients by VA Physician to meet the specific needs of the Veteran.

MedSurg - "Multiple", 760-24-1-050-0243 - Leavenworth CMOP GLUCOSE TEST STRIPS PRINCIPAL NAICS CODE: 325413(In-Vitro Diagnostic Substance Manufacturing) PRODUCT CODE: 6515(Medical and Surgical Instruments, Equipment, and Supplies) Delivery Timeframe: 10 Days ARO

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

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 prescription. No NDC 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 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. The site is not requesting purchase from any certain vendor. Multiple vendors offer these items.

Accordingly, only the supplies described in Section III above will be suitable, and are essential to the Government’s requirements, thereby precluding consideration of a product manufactured by another company.

DESCRIPTION PKG QTY UNIT NDC/SKU#

1 ITEM ID NO. 6243 (XZ173) ONE TOUCH ULTRA

(GLUCOSE) TEST STRIP 50CT (53885-0244-50)

PKG: 50 per BX

50 192 BX 53885-0244-50

2 ITEM ID NO. 6247 ONE TOUCH ULTRA

(GLUCOSE) TEST STRIP 100CT (XZ173) PKG: 100

per BX

100 1800 BX 53885-0245-10

Nature of Urgency: STANDARD Date Needed: 02-18-23

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable:

This will be posted on Contracting Opportunities (Open Market & Service Disabled Veteran Owned SB) with limited competition per Name Brand Only and Gray Market requirements.

SOLICITATION RFQ NUMBER: 36C77024Q0092

ISSUE DATE: 12-12-23

RESPONSE DUE DATE: 12-19-23

PROCUREMENT VEHICLE: Open Market SOCIOECONOMIC CATEGORY: Service Disabled Veteran Owned SB

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable:

The CO will determine the anticipated cost to be considered fair and reasonable based on the following:

Comparison with the IGCE and competitive quotations.

Historical purchases of these MedSurg supplies.

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. The procurement package was received on 12-08-23. Market research is being conducted on 12-12-23 for the upcoming acquisition for "Multiple".

A sources-sought notice was not posted for this acquisition because pharmaceutical buys are routine, and the Contracting Officer is very knowledgeable about the pharmaceutical 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.

A search for both small and large businesses was conducted on the National Institutes of Health (NIH) U.S.

National Library of Medicine DailyMed website using generic terms for the pharmaceutical and the national drug code (NDC) 53885-0244-50, 53885-0245-10.

The Contracting Officer conducted further searches in VetCert utilizing NAICS code 325413 and yielded a total of 86 SDVOSB/VOSBs.

Further market research was conducted via the SBA Dynamic Small Business Search database using the criteria of NAICS code 325413, business type includes Manufacturing, and firms with no more than 500 employee(s), which resulted in 242 small businesses who identified as authorized distributors or manufacturers. Based on procurement history of other pharmaceuticals, it is anticipated that at least two or more of the small businesses are authorized distributors capable of fulfilling VA’s requirement at a fair and reasonable price.

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.

Due to the Class Waiver, the identified SDVOSB/VOSBs comply eligibility requirements in 13 CFR part 121.406 and 13 CFR 125.6.

VA Rule of Two requirements can be met based on the Class Waiver to the NMR and market research.

Due to the SBA regulations and the Nonmanufacturers Rule, as defined in FAR Part 19 and 13 Code of Federal Regulations (CFR) 121.406, in accordance with VAAR Part 13 and 19, an SDVOSB/VOSB set aside is feasible.

As described in Section 6 above, market research, in accordance with FAR Part 10, was conducted by synopsis of the proposed acquisition, and will advise industry of the pending acquisition and soliciting inquiries from interested parties.

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

None

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

Qualified vendors tend to vary from procurement to procurement.

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:

Future acquisitions for these MedSurg' supplies will continue to be solicited as quantities in available stock stabilize and become available in the open market.

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.

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.

Prepared by:

Michael W. McAlhaney Contracting Officer

MICHAEL MCALHANEY Digitally signed by MICHAEL MCALHANEY Date: 2023.12.12 12:49:02 -06'00'

b. One Level Above the Contracting Officer (Required over SAT but not exceeding $700K): I certify the justification meets requirements for other than full and open competition.

Justin Braden Smith Branch Chief Network Contracting Office 15 (NCO 15) - CMOP Division

JUSTIN SMITH Digitally signed by JUSTIN SMITH Date: 2023.12.12 13:02:27 -06'00'