P03_Limiting_Sources_Justification FUL_Redacted.pdf

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6515--Resmed Astral 150 Ventilators
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36C24125Q0791
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This document is a Justification for Limiting Sources (LSJ) for the Department of Veterans Affairs, specifically for acquiring medical equipment. The VA's Network Contracting Office 1 is seeking to purchase twelve (12) ResMed Astral 150 Ventilators (Model No. 27003) with accessories for the White River Junction VA Medical Center, with a total estimated value redacted. The procurement will be made against two GSA contracts (36F79719D0027 and 36F79721D0174) with First Nation Group, LLC and Medical Place Inc, respectively, with additional open market items from Veterans Medical Supply, Inc.

The justification emphasizes the need for these specific ventilators due to Respironics discontinuing production of ventilator lines. ResMed is identified as the only manufacturer with sufficient capability to replace Respironics' workload, and these ventilators are deemed critical for the VA's advanced age population. The document notes the ventilators are user-friendly, with features like touch screen, remote patient usage monitoring, and adaptive ventilation algorithms. The VA is pursuing this procurement under the Simplified Acquisition Threshold (SAT) and intends to award to a Service-Disabled Veteran-Owned Small Business (SDVOSB), maintaining brand consistency with ResMed Astral Ventilators and Homecare Rolling Stands.

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Justification for Limiting Sources for Micro-Purchase Threshold up to the SAT

VHAPG Part 808.405-6 Limiting Sources Page 1 of 3 Revision: 01 Effective Date: 09/01/2024 Acquisition ID#: 36C241-25-AP-5197

DEPARTMENT OF VETERANS AFFAIRS

FAR 8 – Justification for Limiting Sources (LSJ) For

Limiting Sources (<SAT)

Acquisition Plan Action ID: 36C241-25-AP-5197

Contracting Activity: Network Contracting Office 1, Regional Procurement Office East on behalf of the Department of Veterans Affairs, Veterans Integrated Service Networks (VISN 1), . Funding 405-25- 25-1668.

Description of Action: The Contracting Activity is looking to acquire (9) ResMed Astral 150 Ventilators (Model No. 27003) with accessories for VA Healthcare System, Campus.

Order against: GSA Contract Number: 36F79719D0027

Name of Proposed Contractor: First Nation Group, LLC Street Address: 4566 E Highway 20, Suite #208 City, State, Zip: Niceville, FL 32578-8839 Phone: 1-855-221-5332

Order against: GSA Contract Number: 36F79721D0174

Name of Proposed Contractor: Medical Place Inc Street Address: 350 Industrial Park Blvd.

City, State, Zip: Montgomery, AL 36117 Phone: 334-241-0807

OPEN MARKET

Name of Proposed Contractor: Veterans Medical Supply, Inc Street Address: 3200 Tyrone Blvd, City, State, Zip: St Petersburg, FL 33710 Phone: 727-517-4428

3. Description of Supplies or Services:

The total estimated value of the proposed action is . The Contracting Activity is requesting

(12) ResMed Ventilators, Astral 150. The Astral device is intended to be used in home, institution/hospital and portable applications for both invasive and non-invasive ventilation. The Astral 100/150 provides continuous or intermittent ventilatory support for patients weighing more than 11 lb.

(5 kg) who require mechanical ventilation. This device delivers pressure and volume ventilation through

VHAPG Part 808.405-6 Limiting Sources Page 2 of 3 Revision: 01 Effective Date: 09/01/2024 Acquisition ID#: 36C241-25-AP-5197

Justification for Limiting Sources for Micro-Purchase Threshold up to the SAT either a valve or leak circuit and is compatible with a range of accessories to support specific use cases.

At only 7 lbs., Astral is lighter than the market-leading life support ventilator. The Astral 150 Offers the same functionality as Astral 100 as well as a double-limb circuit and Fi02 monitoring. The ventilators used currently in VISN are manufactured by Respironics. In early 2024, Respironics announced that it was discontinuing production and service coverage of several production lines, including ventilators.

The Trilogy 100/200 series ceased production in Dec. 2020 and will no longer be covered for service after Dec. 2025; the EVO Series ventilators’ production ended on Jan. 25, 2024, and service coverage will end Jan. 25, 2029. Besides Respironics, only ResMed has sufficient manufacturing capability to sustain some of the workload from Respironics’ decision. Other vendor ventilator products besides ResMed have not been used or seen by our providers in any volume and lack the capabilities needed for our advanced age population. User-friendly instruction, touch screen, can review patient usage via modem virtually, smaller in size, more mobile. manufactured by OEM LB ResMed, 9001 Spectrum Center Blvd, San Diego, California, 92123. This purchase is for Prosthetics to have stock inventory of ResMed Astral 150 ventilators and Homecare Rolling Stands which provides easy to use ventilation for Veterans with wide range of respiratory disorders to use at home. ResMed Astral 150 has responsive algorithms delivery adaptive, personalized ventilation as the disease progresses. ResMed is the only device that operates on the platform used by most VISN 1 clinicians. These devices are issued to patients after a prescription is issued from the clinicians, these prescriptions do not specify generic products would meet the need. The VA would like to maintain brand consistency with ResMed branded Astral Ventilators and Homecare Rolling Stand. W VA cannot introduce a new ventilator machine into the mix that patients nor staff has experience with, or training on. These facilities do not have any of the supplies and accessories needs for a new branded product to function without unnecessary, additional expenses.

4. Authority:

Order Against FSS: Authority of the Multiple Award Schedule Program, Title III of the Federal Property and Administrative Services Act of 1949 (41 USC 251, et seq.); Title 40 USC 501, Services for Executive Agencies; and Section 803 of the National Defense Authorization Act of 2002 (PL 107-107) and implemented by FAR 8.405-6. Mark the applicable exception:

Items peculiar to one manufacturer. An item peculiar to one manufacturer can be a particular brand name, product, or a feature of a product, peculiar to one manufacturer). A brand name item, whether available on one or more schedule contracts, is an item peculiar to one manufacturer (FAR 8.405-6(b)).

5. Rationale/explanation to support cited authority: Pursuant to 38 U.S.C 8127(b), the Contracting Activity will use other than full and open competition to award to an SDVOSB firm for this procurement under the SAT. These particular ResMed brand ventilators are peculiar to one manufacturer. Government-wide database of contracts and other Government and commercial databases that provide information relevant to agency acquisitions such as SBA VetCert, GSA e- Library, SBA DSBS, and FPDS were queried. The first inquiry was on VetCert using NAICS “334510” yielding 322 broad results. SBA DSBS inquiry using NAICS 334510 along with keyword “ResMed” produced 0 profiles meeting that criteria. GSA e-Library inquiry using keyword “ResMed” returned 3 SDVOSB schedule contractors, First Nation Group, LLC, Medical Place, Inc, and Veterans Medical Supply, Inc, who are all authorized to provide these ventilators, however only the ventilators are on GSA contract, open market accessories are being requested as well. Last search was on FPDS using keyword “Astral 150” which yielded 38 contract actions, most of which were purchases to the VA for the same or similar Astral 150 ventilator. All market research leads to 2 or more SDVOSB distributors

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