S02_JnA_Q0183.pdf

Medical Surgical Items 36C77024Q0183 VHAPG Part 813.5 Simplified Acquisition Procedures for Certain Commercial Items Attachment 1: Request for Brand Name Justification >SAT-$7.5M under FAR13.5

Last Updated: 02/01/22 Page 1 of 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-0327

1. Contracting Activity: Department of Veterans Affairs, Network Contracting Office 15, CMOP Division. 2237 # 761-24-2-014-0146, Chelmsford CMOP, Chelmsford, MA.

2. Nature and/or Description of the Action Being Processed: This procurement is for medical surgical supplies (med/surg) 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.

3. Description of Supplies/Services Required to Meet the Agency�s Needs: This is an individual brand name justification to support the procurement of the medical surgical items listed below in the following table. Items are to be delivered 10 days after receipt of order.

Item Number

File Number

(IMF)

Description MPN or Local Stock Number

Quantity Unit of Measure

Packaging Multiple

0001 13355 ONE TOUCH VERIO

(GLUCOSE) TEST STRIP

(O0346)

53885-0272-10 2400 EA 100

0002 19927 RESERVOIR,T:SLIM X2

W/T:LOCK,3ML 10CT, XL551

1008621 2000 BX 10

0003 761 BAG,LEG LATEX REUSABLE

UROCARE #9532

IDNUC9532 1000 EA 1

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

( ) 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

Attachment 1: Request for Brand Name Justification >SAT-$7.5M under FAR13.5

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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�s prescription. No National Drug Code (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.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: A synopsis of this requirement will be posted to SAM.gov and the RFQ will be posted as a SDVOSB set-aside as there is a SBA NMR waiver for diabetic test strips. Only qualified SDVSOB vendors with direct letters of authorization from the OEM will be able to submit quotes due to Gray Market/Name Brand only requirements.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: The anticipated cost will be fair and reasonable based on competition or the IGCE.

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, VAAR 810, market research has been conducted for this acquisition. The procurement packet was received on January 29, 2024. Market research was conducted on February 26, 2024, for the upcoming acquisition.

Attachment 1: Request for Brand Name Justification >SAT-$7.5M under FAR13.5

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A sources sought notice was not posted for this acquisition because medical surgical (med/surg) buys are routine, and the Contracting Officer is very knowledgeable about the 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, such as and not limited to Prime Vendor, NAC, and FSS. An open market procurement is the only option that remains for purchasing these products.

The Contracting Officer conducted further searches in VetCert utilizing NAICS code 325413 and yielded a total of 83 SD/VOSBs who identified as authorized distributors. Further market research was conducted via Dynamic Small Business search (DSBS) which resulted in 18 small businesses who identified as authorized distributors. These vendors are not manufacturers, but they are distributors for large business wholesalers.

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 to assist in establishing the size, socioeconomic status and domestic availability for each product.

Item Number

Description MPN or Local Stock Number

Manufacturer

0001 ONE TOUCH VERIO (GLUCOSE) TEST

STRIP (O0346)

53885-0272-

Lifescan Inc.

0002 RESERVOIR,T:SLIM X2

W/T:LOCK,3ML 10CT, XL551

1008621 Tandem Diabetes Care

0003 BAG,LEG LATEX REUSABLE

UROCARE #9532

IDNUC9532 Urocare

The Contracting Officer reviewed the Non-Manufacturer Rule (NMR). In accordance with the NMR as defined in 13 CFR § 121.406, the requirement that a Non-Manufacturer supply the product of a small business concern is referred to as the NMR. In order to qualify as a small business concern for a small business set-aside, an offeror must either manufacture the item in accordance with the Limitations on Subcontracting (see FAR section 52.219-14, 52.219-27 and 13 C.F.R. § 125.6) or supply the product of a small business made in the United States. There is an existing NMR class waiver for NAICS 325413 that covers the diabetic test strips in this requirement, posted to the Federal Register in 85 Fed.Reg. 43634 on July 17, 2020. The current list of NMR Class Waivers is maintained by the SBA and can be found at Non-manufacturer rule class waiver list | U.S. Small Business Administration (sba.gov). On June 16, 2016, the U.S. Supreme Court ruled that consistent with Public Law 109-461 (38 U.S.C. 8127 and 8128), the VA shall award contracts based upon competition restricted to SDVOSBs or VOSBs when a contracting officer has a reasonable expectation, based on market research, that two or more firms listed as certified in the SBA�s Veteran Small Business Certification (VetCert) database are likely to submit offers and an award can be made at a fair and reasonable price that offers best value to the United States. This is known as the �VA Rule of Two�. Based on the market research conducted, the CO determined there is a

Last Updated: 02/01/22 Page 4 of 5 reasonable expectation that quotes would be received from two (2) or more SDVOSBs that can comply with the NMR. Although only the diabetic glucose test strips has a waiver, the cost for the test strips covers over 50% the estimated contract value of the requirement. Based on 13 CFR 121.406(d), then a waiver for the other two items not covered by the waiver is not required. There is no requirement that each and every item acquired in a multiple-item procurement be manufactured by a small business or have a class waiver. As the VA strongly encourages maximum SDVOSB/VOSB participation in all requirements, this set-aside decision serves this purpose. As such it is determined to be in the best interest of the Government to utilize other than competitive procedures to set-aside the requirement 100% for SDVOSB concerns to satisfy the VA�s Rule of Two.

The Contracting officer also reviewed the Trade Agreements. In accordance with Far Part 25.401 acqusitions set aside for small businesses is an exception the the Trade Agreements. Furthermore, there is also an exception for acquisitions not using full and open competition or sole source acquisitions justified in accordance with FAR 13.501(a); therefore, the Buy American statute applies to this requirement which is set-aside for SDVOSB concerns and is for the procurement of brand name specific med/surg products.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: This will be a

SDVOSB set-aside based on an existing NMR class waiver for NAICS 325413 that covers diabetic test strips.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: Qualified business 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: No action is being taken at this time due to the fact that no NDC and/or MPN substitutions are permitted based on physician�s specific orders.

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.

Joseph Sousa Date Program Manager Chelmsford CMOP

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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:

Kelley Cunningham Date Contract Specialist Network Contracting Office 15 � CMOP Division

Approved by:

Michael McAlhaney Date Contracting Officer

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

J. Braden Smith Branch Chief Date