P03 H200_Limiting_Sources_Justification_co signed.pdf

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6515--36C26123Q0887 | Bioness H200 and L300 Brand Name Only Palo Alto, CA
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36C26123Q0887
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This justification document supports a limited source procurement by the Department of Veterans Affairs for the Bioness H200 and L300 medical devices from the brand name manufacturer at prices up to the simplified acquisition threshold. The Department of Veterans Affairs Veterans Health Administration seeks to procure these post-stroke rehabilitation devices from Bioness Inc. on a sole source basis due to the specialized nature and unique features of the equipment that have been clinically validated for stroke patients. No other equipment offers equivalent medical efficacy or has received comparable validation through clinical studies and trials. The justification cites the specialized needs of veterans as well as the lack of equivalent alternatives as rationale for the limited competition procurement from the original equipment manufacturer.

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VHAPG Part 808.405-6 Limiting Sources Attachment 1: Justification for Limiting Sources for Micro-Purchase Threshold up to the SAT

Effective Date: 02/01/2022 Page 1 of 3

DEPARTMENT OF VETERANS AFFAIRS

FAR 8 – Justification for Limiting Sources (LSJ)

For Limiting Sources (<SAT)

Acquisition Plan Action ID: __36C261-23-AP-4349____

1. Contracting Activity: Department of Veterans Affairs, VA Sierra Pacific Network (VISN 21), VA Palo Alto Medical Center, Veterans Health Administration Regional Procurement Office West, Network Contracting Officer 21, McClellan, CA 95652-1012.

2. Description of Action: Purchase the Bioness H200 and L300 Wireless Systems which will be utilized in the Polytrauma Intensive Evaluation and Treatment Program (IETP) for the treatment of patients.

Order against: FSS Contract Number: ____V797D-70077_______________

Name of Proposed Contractor: Tryco, Inc.

Street Address: 6736 Old McLean Village Drive City, State, Zip: McLean, VA 22101 Phone: 800 934-3452

Order against: FSS Contract Number: ____V797D-60681_______________

Name of Proposed Contractor: SpecOps Medical Supply, LLC.

Street Address: 3624 County Road 406 City, State, Zip: McKinney, TX 75071 Phone: 214 551-2288

3. Description of Supplies or Services:

The estimated value of the proposed action is $79,812.10

The mission of the Polytrauma Intensive Evaluation and Treatment Program (IETP) is to provide comprehensive evaluation and treatments to Veterans and Service Members who are seen in partnership with the DoD Special Operative Forces with a history of polytrauma or brain injury.

These services include balance, cognitive, visual, sensory and motor rehabilitation interventions. The requested equipment will help address rehabilitation needs for the population through the use of a comprehensive rehabilitation treatment tool that performs functional electrical stimulation in order to treat those with upper and lower extremity

Effective Date: 02/01/2022 Page 2 of 3 pathologies that result from neurological, muscular or skeletal impairments, and to provide cutting edge rehabilitation care. It will be essential to translate the use of these devices in our PTRP/IETP programs since the care for this population of veterans translates to these units as well.

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:

An urgent and compelling need exists, and following the procedures would result in unacceptable delays(FAR 8.405-6(a)(1)(i)(A);

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;

(FAR 8.405-6(a)(1)(i)(B));

In the interest of economy and efficiency, the new work is a logical follow-on to an original Federal Supply Schedule order and the original order was placed in accordance with the applicable Federal Supply Schedule ordering procedures. The original order was not previously issued under sole-source or limited-sources procedures (FAR 8.405- 6(a)(1)(i)(C)); or

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: This a brand name requirement for the Bioness H200 and L300 Wireless System. Patients served in the PTRP/IETP may experience deficits in mobility, strength, proprioception, sensation, muscle function and/or range of motion as a result of their polytrauma or brain injuries. These complex injuries necessitate specialized and custom treatment in order to optimize functional outcomes. The Bioness H200 Wireless Hand Rehabilitation system and Bioness L300 Go ease hand and foot function overall. Bioness, the recommended contractor, offers both a Foot Drop System and Wrist/Hand Orthosis which will allow clinicians to offer a broad scope of rehabilitation benefits such as increasing/maintaining range of motion, reducing painful muscle spasms, preventing muscle atrophy, improving circulation, reeducating muscles and increased function with requested features to meet the specialized program requirements and address these patients’ complex needs.

Effective Date: 02/01/2022 Page 3 of 3

The Bioness H200 and L300 are fully integrated systems equipped with a Functional Electrical Stimulation Orthoses, control units and clinician’s programmer. They offer advanced and customized technology to stimulate the appropriate nerves and muscles in the forearm, hand, leg, and foot. Additionally, they are fully wireless systems that are ergonomically designed, easy to operate and fully programmable to meet the needs of a patient-specific therapy program and allows for grasping, reaching, and opening and closing of the hand during functional activities. Furthermore, the system allows to help improve and progress gait, balance, and safety for those with foot drop.

6. BRAND NAME ONLY: This buy is estimated to exceed $25,000 and this documentation will be posted along with the RFQ on e-Buy, as required by FAR 8.405-1(e).

7. Note that this determination satisfies the requirements of FAR 8.405-6. The requirement to prepare a written justification IAW FAR 6.303 does not apply to Federal Supply Schedules.

Edward B. Hunter Angela M. Oppenheimer Contract Specialist, Supply I Contracting Officer, Supply I

NCO 21 NCO 21

2023-08-15T18:33:53-0700
EDWARD HUNTER
2023-08-17T11:23:18-0700
ANGELA OPPENHEIMER

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