Limiting_Sources_Justification_OVER_SAT Envella Bed_Redacted.pdf

RFO Part 8.401 Limiting Sources Page 1 of 5 Acquisition ID#: 36C248-26-AP-0863

LIMITED SOURCES JUSTIFICATION

ORDER >SAT

RFO PART 8.401

Acquisition Plan Action ID: 36C248-26-AP-0863

(1) Contracting Activity: Department of Veterans Affairs, Veterans Health Administration, Regional Procurement Office East, Network Contracting Office 08 (NCO 08) on behalf of Bay Pines VA Healthcare System located at 10,000 Bay Pines Blvd. Bay Pines, FL 33744.

2237:

(2) Description of Action: This acquisition is conducted under the authority of the Multiple- Award Schedule Program (41 U.S.C. 152(3) and 40 U.S.C. 501).

Order against: FSS Contract Number: 36F79721D0160

Name of Proposed Contractor: Hill-Rom Company, Inc.

Street Address: 1069 State Rt 46 E

City, State, Zip: Batesville, IN 47006

Phone: 317-679-6639

(3) Description of Supplies or Services:

The estimated value of the proposed action is $

The Bay Pines VA Health Care System requires the rental of air fluidized therapy beds for the treatment of Veterans with complex wounds. The specific items are:

• P0819A – Envella™ Air Fluidized Bed

• P0821A – Envella™ Air Fluidized Bed with Trapeze

The Hillrom Envella™ Air Fluidized Therapy (AFT) Bed is a highly specialized hospital bed designed for patients with complex wounds, such as pressure injuries, burns, or grafts. It uses air-fluidized therapy to reduce pressure and shear, manage moisture, and promote healing.

These beds must provide:

RFO Part 8.401 Limiting Sources Page 2 of 5

• True air-fluidized therapy using microsphere technology

• Adjustable immersion and envelopment for individualized wound care

• Advanced moisture and shear management

• Trapeze support for mobility without compromising wound sites

• Infection control design suitable for immunocompromised patients

This requirement will be a Delivery Order with a base and four option years to procure the Hillrom Envella™ Air Fluidized Therapy (AFT) Bed for the Bay Pines VA Healthcare System. The effective date of the Delivery Order is to be 1 January 2026.

Base Year: January 1, 2026 – December 31, 2026 Option Year 1: January 1, 2027 – December 31, 2027 Option Year 2: January 1, 2028 - December 31, 2028 Option Year 3: January 1, 2029 - December 31, 2029 Option Year 4: January 1, 2030 - December 31, 2030

(4) Identify the Authority and Supporting Rationale (see below and if applicable, a demonstration of the proposed contractor’s unique qualifications to provide the required supply or service.

GSAR 538.7104-3(b)(i): An urgent and compelling need exists and following the ordering procedures would result in unacceptable delays:

GSAR 538.7104-3(b)(ii): Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized; (Brand-Name). The Hill-Rom Envella™ Air Fluidized Therapy Bed incorporates a range of proprietary, clinically validated technologies that are not available from other manufacturers. These include advanced wound care modalities, continuous lateral rotation therapy (CLRT), and customizable immersion and envelopment settings that adapt to a wide spectrum of patient conditions, including those with Stage III/IV pressure injuries, burns, flaps, and grafts.

Hill-Rom holds exclusive proprietary rights to the medical technologies embedded in the Envella™ system, making them the sole source provider for this specific therapeutic platform.

The Envella™ bed has been shown in clinical studies to:

• Reduce pressure injury progression and promote faster healing through optimized pressure redistribution and microclimate management.

• Improve pulmonary outcomes in immobile patients through CLRT, which has been associated with reduced incidence of ventilator-associated pneumonia (VAP) and improved oxygenation.

• Enhance patient comfort and reduce pain by minimizing shear and friction forces, which are critical in patients with fragile skin or compromised tissue integrity.

RFO Part 8.401 Limiting Sources Page 3 of 5

• Support infection control protocols with seamless surfaces and materials designed to reduce bacterial colonization and facilitate effective cleaning.

A 2020 clinical evaluation published in Advances in Skin & Wound Care found that air-fluidized therapy beds like the Envella™ significantly improved wound healing rates and reduced hospital length of stay in patients with complex wounds. Additionally, internal VA clinical data and Hill- Rom case studies have demonstrated improved patient outcomes, reduced readmission rates, and lower overall cost of care when Envella™ beds are used as part of a comprehensive wound care strategy.

Given the critical nature of the patient population served at the Bay Pines VA Healthcare System, the Envella™ bed is not only clinically appropriate but essential to delivering evidence-based, high-quality care to Veterans with advanced therapeutic needs.

GSAR 538.7104-3(b)(iii): In the interest of economy and efficiency, the new work is a logical follow-on to an original Federal Supply Schedule order provided that the original order was placed in accordance with the applicable Federal Supply Schedule ordering procedures. The original order must not have been previously issued under sole source or limited source procedures.

GSAR 538.7104-4: Items peculiar to one manufacturer:

A patent, copyright or proprietary data limits competition. The proprietary data is:

These are “direct replacements” parts/components for existing equipment.

The material/service must be compatible in all aspects (form, fit and function) with existing systems presently installed/performing.

(5) Describe Why You Believe the Order Represents the Best Value consistent with FAR 8.401 to aid the contracting officer in making this best value determination: The anticipated cost will be considered fair and reasonable utilizing the information on the price schedules above.

Supplies offered on the schedule are listed at fixed prices. GSA has already determined the prices of supplies under schedule contracts to be fair and reasonable.

(6) Describe the Market Research Conducted among schedule holders and the results or a statement of the reason market research was not conducted. Market research efforts include queries on Small Business Search, Federal Procurement Data System (FPDS), General Services Administration and System for Award Management (SAM). The North American Industry Classification System (NAICS) code is 339112 (Surgical and Medical Instrument Manufacturing);

W065 (Lease or Rental of Equipment –Medical, Dental, and Veterinary Equipment and Supplies).

RFO Part 8.401 Limiting Sources Page 4 of 5

There is no nonmanufacturer class waiver for the NAICS code 339112 for Surgical and Medical Instrument Manufacturing listed on the NMR Class Waiver Database. An SDVOSB cannot qualify as a nonmanufacturer for this requirement because it cannot meet the four-prong test of 13 CFR 121.406(b) where the fourth prong specifically requires the nonmanufacturer to supply products from a small business not a large business.

The requirement was initially solicited as a Brand Name or Equal in September 2025 by Contracting Officer Colleen Houser, under RFQ 36C24825Q1091. Upon review, all bids received were for Air Loss Beds, which were not technically acceptable. A thorough query of the NAC Med/Surg Catalog, Supply Chain Master Catalog, Med PDB, and GSA Advantage databases was conducted to identify applicable contracts. This search identified Hill-Rom FSS Contract #36F79721D0160, which confirmed the requested items are on contract.

FPDS was queried utilizing the keywords “Envella” and filtered for the Department of Veterans Affairs showed results of 30 Delivery Orders between 11/2025 – 1/2024. All Delivery Order were awarded through FSS/GSA to Hillrom (Large Business). The Analytics, Data and Decision Support Unified Platform (ADDS UP) was also quired using the simple search Envella” and identified 41 active Delivery Orders. Of the 41 actions, only 2 were awarded outside the FSS/GSA contract.

Based on the clinical necessity, lack of equivalent alternatives, and manufacturer exclusivity, it is recommended that the Hill-Rom Envella™ Air Fluidized Bed (P0819A and P0821A) be procured on a brand name basis to support critical patient care at the Bay Pines VA Health Care System.

(7) Any Other Facts Supporting the Justification: Hillrom (now part of Baxter) is the sole manufacturer and distributor of the Envella bed, meaning no third-party vendors can legally sell or rent it. Continuity of care and standardization is also a consideration for justification. Envella integrates better, reducing training and maintenance complexity. Therefore, standardizing on one vendor can reduce clinical errors, training time, and service costs.

(8) A Statement of the Actions, if any, the agency may take to remove or overcome any barriers that led to the restricted consideration before any subsequent acquisition for the supplies or services is made: The Government will continue to conduct market research to ascertain if there are changes in the marketplace that would enable future actions to be competed.

(9) 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. I understand that processing of this limited source justification restricts consideration of Federal Supply Schedule contractors to fewer than the number required by FAR Subpart 8.4. (This signature is the requestor’s supervisor, fund control point official, chief of service or someone with responsibility and accountability.)

RFO Part 8.401 Limiting Sources Page 5 of 5

Supervisory Inventory Management Specialist Bay Pines Veterans Affairs Healthcare System

(10) Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

a. Contracting Officer’s Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Contracting Officer Network Contracting Officer (NCO) 08