S02 - J and A - LEG BAG - Q0275 - REDACTED.pdf

VHAPG Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source

Revision: 01 Effective Date: 11/15/2024 Page 1 of 4 Acquisition ID# 36C77025Q0275

DEPARTMENT OF VETERANS AFFAIRS

Justification for Single Source Awards IAW FAR 13.106-1 For

Over Micro-Purchase Threshold but Not Exceeding the SAT ($250K)

Acquisition Plan Action ID: 36C770-25-AP-0668

1. Contracting Activity:

Department of Veterans Affairs, RPO Central Lancaster CMOP Network Contracting Office 15 2962 S. Longhorn Drive 3450 S. 4th Street Lancaster, TX 75134-2118 Leavenworth, Ks. 66048

2237#: 763-25-3-021-1300

2. Brief Description of Supplies/ Services required and the intended use/Estimated Amount:

This is an individual brand name justification to support the procurement of the one (1) Brand Name Specific Med/Surg item LEG BAG COMBO PK H#9349 LATEX FREE (XZ156). The proposed procurement action will be a firm-fixed-priced contract. Per the OEM, Product is a Vinyl, Latex-Free Urinary Leg Bag Combination Pack, which includes 1 Leg Bag, 18" Extension Tubing with Connector, Pair of 23" Fabric Leg Bag Strap. The estimated amount of this procurement is

Item Number

CMOP

Location

Description Part Number

Quantity Unit of Measure

Packaging Multiple

Unit Price

Manufacturer Country of

Orgin

Usage

0001 VA CMOP

LANCASTER

290 LEG

BAG

COMBO PK

H#9349

LATEX FREE

(XZ156) 12

per BX

(BRAND

SPECIFIC)

9349 600 BX 12

HOLLISTER TBD It is used by individuals who have difficulty controlling their urination due to various medical conditions, including urinary incontinence, urinary retention, or after certain surgeries.

3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used:

Product has 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

Effective Date: 11/15/2024 Page 2 of 4 Acquisition ID# 36C77025Q0275 dispense as written on a physicians prescription. No National Drug Code (NDC)/ or specific Manufacture Part Number (MPN) 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 or MPN but 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 or perform specific function to match the product code.

4. Description of market research conducted and results or statement why it was not conducted:

A sources sought notice was not posted for this acquisition because 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. A competitive solicitation will be posted to SAM.gov

In accordance with FAR Part 10, VAAR 810, and VAAM M810 market research has been conducted for this acquisition. The following techniques were used and the timeframes/date of the researchThe Consolidated Mail Outpatient Pharmacy (CMOP) has identified that the Brand Specific 290 LEG BAG COMBO PK H#9349 LATEX FREE (XZ156) 12 per BX are to be acquired from only Hollister, a large business. The request for the brand specific product comes directly from the VA Medical Center Doctors. Market research confirmed that the med/surg product is not available from typical contract vehicles or supply chains. All avenues have been exhausted by CMOP via searches on Prime Vendor, FSS and NAC by brand name product number yielded no results; an open market procurement is the only option that remains for purchasing the med/surg products. This requirement is not for lack of planning, but due to inventory not being available via normal supply chains.

The additional Market Research below will show a search on the National Acquisition Center (NAC) Med/Surg database catalog confirms that product is not available from Prime Vendors.

Daily Med was searched and yielded nothing as expected, Med/Surg items are usually not found in their database but was utilized to be thorough.

Effective Date: 11/15/2024 Page 3 of 4 Acquisition ID# 36C77025Q0275

The Medical Image Library was searched and the manufacturer was determined to be Hollister, a large business.

The SBA�s DSBS databases were checked for the manufacturers of the Brand Specific 290 LEG BAG COMBO PK H#9349 LATEX FREE (XZ156) 12 per BX, none of the keywords in the manufacturer search yielded results. Confirming that the manufacturers/ OEMs are not registered with the SBA DSBS.

The station provided an approved (Manufacture Part Number) for the requested Brand Specific 290 LEG BAG COMBO PK H#9349 LATEX FREE (XZ156) 12 per BX. The first query was conducted within GSA.gov, in order to gather photos and confirm the manufacturers/OEMs names and it yielded no results. A second search was done within Google.com in order to gather photos and the manufacturers/OEM names and it yielded and unmeasurably amount of websites. Hollister was among the list with the requested as shown here.

https://www.hollister.com/en/products/continence-care-products/urine-collectors/leg-bag-systems/urinary-leg-bag-combination-pack

Cross-referencing the Manufacture's website information with the databases SAM.gov, the DSBS, and/or other search engines (e.g., Google, U.S. Securities and Exchange Commission's EDGAR), the manufacturer, "Hollister Incorporated" of the requested Med/Surg has been determined a large business concerns.

The contract type will be firm-fixed-price since the price will not be subject to any adjustment on the basis of the contractor's cost experience in performing the contract. This contract type places upon the contractor maximum risk and full responsibility for all costs and resulting profit or loss.

In accordance with FAR Part 25, the Buy American Act (BAA) applies because the procurement is a small business set-aside FAR 25.l0l(b).

Reviewing the past procurement showed the item being made in the

USA.

Vendor shall be an OEM, authorized dealer, authorized distributor, or authorized reseller for the proposed equipment/system, verified by an authorization letter or other documents from the OEM. All software

Effective Date: 11/15/2024 Page 4 of 4 Acquisition ID# 36C77025Q0275 licensing, warranty and service associated with the equipment/system shall be in accordance with the OEM terms and conditions.

The Contracting Officer reviewed the Non-Manufacturer Rule and its applicability to the procurement action. The nonmanufacturer rule applies to socioeconomic specific small business categories for contracts valued above the micro-purchase threshold, but does not apply to total (non-socioeconomic specific) small business set-asides below the SAT. 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 business concerns have 500 or less employees, engage in the retail wholesale trade and normally sell pharmaceuticals/Medical Surgical items, take ownership or possession of the pharmaceuticals/ Med/Surg items via its facilities or via its personnel. However, market research concludes that there are presently no domestic small business concern manufacturers that exist in the commercial marketplace for the Med/Surg Product. The CO has confirmed there is no class waiver associated for the Med/Surg item 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. Given this information, a socioeconomic specific set-aside may not be feasible as vendors would not be able to comply with the NMR without a waiver of the fourth prong. Alternatively, a total small business set-aside is feasible as the NMR does not apply to total small business set-asides below the SAT.

5. Contracting Officer's Certification: Purchase is approved in accordance with FAR13.106-

1(b). I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Jennifer Coleman Jennifer Knight Contract Specialist Contracting Officer