6515--FES ELEC STIM PT BIKE (2)

Special Notice Special Notice Page 6 of 6 *= Required Field Special Notice Page 1 of 6 NOTICE OF THE INTENT TO SOLE SOURCE TO RESTORATIVE THERAPIES, INC., 8098 Sandpiper Circle, Ste M, Nottingham, MD 21236, UNITED STATES. Response Due Date: February 16, 2024, by 12:00PM (EST) NOTICE OF THE INTENT TO SOLE SOURCE SYNOPSIS Network Contract Office 1, Procurement Office East on behalf of The Department of Veterans Affairs, West Roxbury VA Medical Center located at 1400 VFW Parkway, West Roxbury, MA 02301 intends to award a firm-fixed contract with no options to RESTORATIVE THERAPIES, INC to provide delivery and training for (2) RT300 Neurological Rehabilitation System. The proposed procurement is for products for which the Government intends to solicit and negotiate with only one source under the authority of FAR 6.302-1 -- Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements. 41 U.S.C. 3304(a)(1). The North American Industry Classification System code (NAICS) for this requirement is 334510. All responsible sources that feel they should be considered qualified to provide the above-mentioned products may submit a response to this notice (by the response due date shown above) to contact@example.gov. The information provided shall include detailed (and relevant) documentation to allow the government to perform adequate market research and make a proper determination. A determination by the government not to compete this proposed requirement based upon responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. THIS IS NOT A REQUEST FOR COMPETITIVE PROPOSALS. THERE IS NO SOLICITATION AVAILABLE AT THIS TIME. REQUESTS FOR A SOLICITATION WILL NOT RECEIVE A RESPONSE. STATEMENT OF WORK BOSTON VA HEALTHCARE SYSTEM RT300 The Contractor is asked to provide Clinic, RT300-SLSA 6 Channel FA104581C in the procurement and deployment of Clinic, RT300-SLSA 6 Channel FA104581C. The Department of Veteran Affairs, VISN 01, VA Boston Healthcare System due to numerous factors has a requirement for: 2 Restorative Therapies Functional Electrical Stimulation (FES) Upper and Lower Extremity Cycles (RT 300) to be used in the Physical Medicine and Rehabilitation Gym in West Roxbury. REQUIREMENT OVERVIEW The scope of this procurement is to use pulses of electrical current to stimulate peripheral nerves. FES is applied using adhesive pads placed over the muscle to be activated. When activated, it generates muscle contractions and patterned muscle activity. With restorative therapies systems, FES creates patterned movement in the arms, legs and trunk. In people with weak or paralyzed muscles, FES enables muscles to work and perform activities, even if the individual may not be able to consciously participate. Users can also stimulate core erector spinal muscles and abdominal muscles during the therapy session. This group of muscles are important for posture, balance, transferring, reaching and coughing. VA-MDNS Category or Product Description Model Clinic, RT300-SLSA 6 Channel FA104581C RT300-SLSA, Clinic 6 Channel 115V FES cycle with electrical stimulation for arms, legs & trunk - SAGE controller - Left RT60 six channel stimulator - Stimulation cable - Rams horn hand grips and arm rests with bar grip - Gloves 2 pair - Adjustable UE crank arms for pediatric - 10 sets of electrodes - Clinic training - 36 month manufacturer s warranty FA104581C The services shall be in accordance with the tasks and deliverables as described in this statement of work (SOW). The contractor shall provide technical support both in the setup and calibration of each device but also integration with the existing Alaris Systems Manager and EHR system in use at the facility. In addition, the contractor will provide clinical user training, as needed, to ensure safe operation of the new hardware. Final acceptance is completed once all deliverables have been received and turnover / go live has been completed. The contractor shall communicate any enhancements these new units may have to the local point of contact (POC) and contracting office representative (COR). All activities related to this resultant contract shall be in the best interest of the VA and coordination of all activities shall be planned accordingly. All equipment procured under this resultant contract shall be compatible with the firmware and software of the current infusion equipment in use at the facility. Facility Name Delivery Address Model Quantity VA BOSTON HEALTHCARE SYSTEM 1400 VFW PARKWAY, WEST ROXBURY, MA 02132 FA104581C 2 TECHNICAL REQUIREMENTS Hardware: The CLINIC, RT300-SLSA 6 CHANNEL shall be FA104581C units. 1. Connect the AC mains cord to the "Y" cable. 2. Plug one end of the "Y" cable into RT300 base. 3. Plug the other end of the "Y" cable into the AC adapter. 4. Plug the AC adapter output into the base of the RT300 The proposed RT300 FES system shall be RT300-SLSA units. The proposed RT300 shall be able provide FES to the legs and core for seated FES leg therapy and to the core for non-FES arm therapy (Stimulation Leg, no stimulation Arm) The proposed sage controller shall be FA104581C units. The proposed left RT60 six channel stimulator shall be FA104581C units. The proposed stimulation cableFA104581C units. The proposed rams horn grips and arm rest w/ bar grip, gloves (2 pair), adjustable UE crank arms for pediatric, 10 sets of electrodes shall all be FA104581Cunits. Integration The proposed SAGE controller shall be able to connect to VA wireless network (WIFI) to allow access to RTIlink. Information Security All VA sensitive information shall be protected at all times, in accordance with VA local site guidelines. The Contractor shall report any known or expected security/privacy incidents, or any unauthorized disclosure of sensitive information, to the COR. Any wireless connectivity to the VA network must be compatible with 802.11b/g/n and compliant with VA Information Security policies. Any remote service support requires a memorandum of understanding/interconnection security agreement (MOU/ISA) with the VA. The Contractor shall follow all Government rules and regulations regarding information security to prevent disclosure of sensitive information to unauthorized individuals or organizations, and shall adhere to all VA Privacy & Security, the Privacy Act, and Health Insurance Portability and Accountability Act (HIPPA) requirements when obtaining and reviewing information. TRAINING REQUIREMENTS Clinical Training Training shall be provided by Restorative Therapies. service requirements Service and Operator Manuals The Contractor shall provide the following documentation for the proposed systems: Two (2) copies of operator instruction manuals (one (1) electronic and one (1) physical copy) Two (2) copies of service manuals (one (1) electronic and one (1) physical copy) *Contractors can include the physical copy as a priced line item in their quote as applicable. Minimum Warranty The system and accessories shall be covered under the manufacturer s warranty and shall include all parts and labor for one year following acceptance by the VAMC. TRAVEL OR SPECIAL REQUIREMENTS The Contractor shall submit all proposed travel plans to Contracting Officer (CO) and Contracting Officer Representative (COR) for review and approval no less than 5 business days in advance of the anticipated departure date. Travel costs will be included in task orders. The principal place of performance for services provided in the SOW is projected to be at the Contractor s site. However, the contractor may be required to attend meetings at the Government site location. - Additionally, the Contracting Officer s Representative (COR) must approve all travel requirements/requests before travel begins. Travel that occurs without pre-approval by the COR will NOT be reimbursed (See Attachment Travel Authorization Request Form). Travel and per diem expenses shall be in accordance with Federal Travel Regulations and FAR 31.205-46. PERFORMANCE PERIOD The period of performance (POP) shall be defined as the date of the award of this contract until all deliverables have been accepted. This period of performance shall not exceed one calendar year. Normal hours of work are defined as Monday through Friday from 8:00am to 7:00pm in the local facility time zone (or as specified by VISN / Facility), excluding Federal holidays, or as otherwise arranged with the COR. There are eleven (11) Federal holidays set by law (USC Title 5 Section 6103) that VA follows: Under current definitions, five (5) are set by date: New Year s Day January 1 Juneteenth National Independence Day June 19 Independence Day July 4 Veterans Day November 11 Christmas Day December 25 other information/documentation requested Completed Manufacture Disclosure Statement for Medical Device Security (MDS2) form Product brochures Technical specification sheets, to include dimensions and weight of the system Typical drawings (pdf version of the CAD drawings) 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: 36C241-23-AP-3936 Contracting Activity: Network Contracting Office 1, Regional Procurement Office East on behalf of the Department of Veterans Affairs, VISN 1, West Roxbury VA Medical Center, 1400 VFW Parkway, West Roxbury, MA 02132-4927. Funding 523-23-3-7821-0165. Brief Description of Supplies/ Services required and the intended use/Estimated Amount: This is a new, brand name requirement. The Contracting Activity is seeking delivery and training for (2) RT300 s Systems for Neurological Rehabilitation. This equipment is manufactured and solely distributed by small business Restorative Therapies, Inc. 8098 Sandpiper Circle, Suite M, Nottingham, MD 21236 (UEI: FRQZHHSQM413) The RT300 product line incorporates functional electrical stimulation (FES) integrated with motor assistance/resistance activities to optimize therapeutic goals. This equipment will be used in the Physical Medicine and Rehabilitation Gym in West Roxbury. The rehabilitation gym in West Roxbury sees a variety of individuals with neurologic diagnoses including but not limited to complete/incomplete SCI/D, Multiple Sclerosis, Traumatic Brain Injury and Cerebral Vascular Accident. These patients require the use of integrated functional electrical stimulation to promote muscle contractions to weak or paralyzed muscles that cannot be performed by other means. Individuals with neurologic injuries require mass practice and high intensity therapy. FES cycling is one of the only ways to achieve their unique rehabilitative needs. These individuals benefit from this evidence based intervention in conjunction with other interventions to promote recovery of functional LE tasks such as functional transfers and walking as well as UE tasks such as dressing, bathing, eating and grooming. Veterans who are unable to attain functional tasks due to their level of injury benefit from FES to complete cardiovascular exercise that cannot be performed by other means. Published therapeutic benefits include improved cardiovascular peak oxygen update, decreased vascular resistance and improved blood flow, improved body composition and metabolic factors and the potential for reversal or preservation of bone density. Estimated Value $63,423.00. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used: Functional electrical stimulation units were extensively searched, and several other products have been trialed and explored by the rehab department at the West Roxbury VA. Aspects considered in the search and trial included usability, specifically for the neurologic population, training requirements and customer service support for ongoing updates and maintenance. To the best of their knowledge Restorative Therapies FES cycles is the only product on the market that offer stimulation to upper and lower extremities and provides a customizable therapy. Other electrical stimulation units do not offer the same level of intensity as FES cycling as they often only stimulate 1-2 muscle groups at a time where the FES cycle can stimulate 6 muscles. Other options lack the repetitive and cyclical pattern that is necessary for neurologic reeducation. Therefore, comparable products do not match the ease of use, specificity and intensity needed for individuals with neurologic conditions. Description of market research conducted and results or statement why it was not conducted: The Contracting Activity conducted its first search on VetCert using NAICS 334510 generated 299 broad results, none of which are authorized to provide this rehabilitation equipment. SBA DSBS search using NAICS 334510 along with keyword Restorative Therapies which returned 0 results. GSA search using keyword Restorative Therapies borne 1 schedule contractor who was the OEM SB RESTORATIVE THERAPIES, INC. under GSA contract 36F79719D0096. FPDS search using keyword RT300 under Contracting Office 01 produced 6 contract actions for similar equipment from Restorative Therapies to various locations within VISN 1. NAC search using catalog number FA104581C yielded 0 active items. Last search was on VetBiz using NAICS 334510 along with keyword Restorative Therapies which yielded 0 organizations. OEM SB Restorative Therapies President & CEO James Janicki states that they are the designers, manufacturers and the only distributor of the RT300 systems worldwide. This statement was supported with a sole source letter signed by the CEO. Since this requirement is above $25,000, an intent to sole source notice was published to Contract Opportunities IAW FAR 5.203 on 08/02/2023 with a closing date of 08/09/2023. The rule of two was not met. 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.