P03 SSJ.pdf

VHAPG Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Attachment 1: Single Source Justification for SAP under the SAT

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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: 36C250-24-AP-1660

1. Contracting Activity: The Department of Veterans Affairs, Veterans Integrated

Service Network (VISN) 10, Louis Stokes Cleveland Veterans Affairs Medical Center (CLE VAMC) Network Contracting Office (NCO) 10.

Transaction: 541-24-3-250-0131

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

(a) Description of Supplies: The request is to purchase an ArmeoPower with

Manovor Power.

The Department of Veterans Affairs, CLE VAMC requires a purchase order for the procurement of an ArmeoPower with Manovor Power. The ArmeoPower with Manovor Power will be for use in the Spinal Cord Injury Department (SCI), includes the following:

1 EA ArmeoPower with Manovor Power 1 EA Armeo Cart

VA requires a device capable of supporting distal upper extremity interventions as well as hand and wrist interventions.

(b) ESTIMATED DOLLAR VALUE: $241,676.00

(c) REQUIRED DELIVERY DATE: 150 Days ARO

3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used: Hocoma Inc., is uniquely qualified to provide a robotic therapy device based on the following:

Patients served by CLE VAMC SCI are often individuals who possess upper extremity deficits due to their spinal cord injuries and disorders. These patients are significantly limited in their strength, range of motion or ability to complete activities of daily living. Traditionally, therapists address these challenges with external supports, manual assistance, or repetitive exercises which can be unmotivating.

Although traditional measures can be common, the lack of challenge and intensity

Last Updated: 02/01/22 Page 2 of 5 can frustrate the individual’s rehabilitation experience. The need for constant therapist guidance creates inefficiencies and may contribute to a delay in the potential neurological recovery of the individual. The additional time that it takes to set the patient up with supports and different therapeutic activities can create logistical barriers to maximizing time spent working on the desired functional skills.

Evidence based practice suggests the use of interventions involving exoskeletons in the recovery of neurological conditions such SCI and stroke. We currently have an exoskeleton intended for lower extremity recovery, but we have no such device for recovery and intervention specific to the upper extremity. The ArmeoPower will be an essential part of occupational therapy interventions for veterans diagnosed with tetraplegia and other upper extremity deficits. Many of our veterans also chronic and acute shoulder injuries which also prevent and limit meaningful engagement in daily tasks. Using the ArmeoPower, therapists can provide intense therapy at a level that meets the needs of the individual patient. The interactive software and robotic assistance can allow patients to train earlier in their rehabilitation. With the orthopedic population, the ArmeoPower can provide decreasing assistance to patients as they regain strength following surgery or injury which can help them progress over time. Use of this technology would dramatically increase the rehabilitation staff’s capacity to address patients’ goals by safely delivering intense, challenging therapy.

Apart from offering challenging virtual environments and games, the ArmeoPower with Manovor Power also allows for a comprehensive assessment of a patient’s range of motion and functional capacity. Objective, repeatable measures allow therapists to accurately record a patient’s abilities and track their progress over time. These thorough reports assist therapists to guide their treatments to improve the patients’ greatest limitations. The assessment feature also produces easy to read graphs and charts which illustrate to patients the progress that they have made during their rehabilitation.

The ArmeoPower provides full robotic function at the shoulder, elbow and wrist;

utilizes sensors and intuitive software to engage patients in their therapy through functional exercises and motivating games; provides virtual reality feedback for both assessments and treatments; includes a pressure sensitive handgrip to assist with hand opening and closing.; can objectively assess joint range of motion; and isometric torque, movement workspace and movement quality, and produce therapy reports.

Please see section 4 below to see the three other three brands of robotic therapy devices that don’t meet the requirement.

4. Description of market research conducted and results or statement why it was not conducted: Hocoma Inc., is uniquely qualified to provide robotic therapy device based on the following:

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VetCert, DSBS, National Contracts, Interagency Contract Directory, GSA, FSS, , BIC, FPDS, DLA Troop Support Medical Supply Chain and the Internet were reviewed with the following results:

VetCert was queried, as required, using NAICS 334510. The search provided 309 results. Veteran Small Business Certification (sba.gov)

The OEM, Hocoma Inc., was contacted to receive a list of authorized distributors, with a concentration on SDVOSB and VOSB authorized distributors and to determine in what country(ies) the robotic therapy device is manufactured. The ArmeoPower with Manovor Power is manufactured in Switzerland. The OEM contact, Matthew Klock, stated that Hocoma Inc. is the manufacturer of the ArmeoPower with Manovor Power, and currently does not use distributors for this ArmeoPower with Manovor Power.

A search was conducted in Small Business Administration (SBA) Dynamic Small Business Search (DSBS) SBA - SBA Search Results under NAICS CODE 334510 and key words robotic therapy device with no results.

A search was conducted on the Interagency Contract Directory Interagency Contract Directory Portal with key words robotic therapy device with no results.

A search was conducted on GSA eLibrary Search Results (gsaadvantage.gov) with key words robotic therapy device with no results.

A search was conducted in Federal Procurement Data System (FPDS) FPDS-NG ezSearch with key robotic therapy device with no result.

IAW MB Memorandum M-19-13 Category Management: Making Smarter Use of Common Contract Solutions and Practices, this requirement cannot be satisfied through Best in Class contracting (BIC).

A search was conducted in The U.S. Food & Drug Administration (FDA) Search | FDA with key words robotic therapy device with no results.

A search was conducted on The DLA Troop Support Medical Supply Chain Medical Supply Chain Homepage (dla.mil) with key words “robotic therapy device” with no results.

Additional market research conducted :

Manufacturer Make/Model Place of Manufacture

Why this model wouldn’t work

Barrett BURT Massachusetts, Only supports the

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USA distal upper extremity, no option for additional components for hand and wrist interventions

KinArm KinArm Exoskeleton Lab

Canada Intended for research purposes and not clinical interventions

Harmonic Bionics Harmony SHR Texas, USA Does not include interactive gaming system, does not measure objective data for progress assessment, does not include task specific activities to elicit mass repetition of movements

Hocoma Inc. ArmeoPower Switzerland This item would work because it provides full robotic function at the shoulder, elbow and wrist; utilizes sensors and intuitive software to engage patients in their therapy through functional exercises and motivating games; provides virtual reality feedback for both assessments and treatments; includes a pressure sensitive

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In summary, the robotic therapy device presented by Hocoma Inc. as addressed by the above market research, is presented to be the only option which will meet the Cleveland Veterans Affairs Medical Center (CLE VAMC) Spinal Cord Injury (SCI) program’s specific needs.

The NMR does apply to NAICS 334510, and SBA has provided a class waiver for

NAICS 334510.

Based on the market research conducted, no two or more VetCert verified and capable SDVOSBs or VOSBs or DSBS verified small business were identified and appeared capable of performing the requirement. The VA Rule of Two and SBA Rule of Two cannot be met.

FITARA is not needed for this requirement, it is not IT related.

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.

Rachelle J. Hamer Contracting Officer Network Contracting Office (NCO) 10 handgrip to assist with hand opening and closing.; can objectively assess joint range of motion and isometric torque, movement workspace and movement quality, and produce therapy reports.