6530--VISN H-Wave H4

Statement of Work Statement Multi-Function Electrical Stimulation Device H Wave H4 Introduction/Overview The Consolidated Prosthetics Unit (CPU) needs to procure a brand name Multiphasic Stimulation Device. This device is listed as the H-Wave H4. This device produces a specific wave form or H Wave that is unique to this device and is being issued by VA providers to support Veteran recovery after surgery, to restore function, and manage chronic/acute or post-operative pain. 1.1 Background VISN 17 instituted a centralized distribution center for the express purpose of distributing over 107 products lines to support all VISN 17 Prosthetics offices. However, due to the success of the CPU, demand for this product has exceeded the current acquisition methods and requires a more robust and flexible method of obtaining these devices. In order to fulfill the material supplies required for uninterrupted operation of its mission, VISN 17 intends to establish an Indefinite Delivery/Indefinite Quantity contract (ID/IQ) with qualified sources of supply (i.e. suppliers) as a simplified method for filling anticipated repetitive needs for supplies via an established contract. The Government therefore intends to issue ID/IQs at fair and reasonable prices. Historically, amongst all suppliers, VISN 17 has required and will require in the future an estimated 1800 H-Wave devices per year. While the Government anticipates this level of demand to continue in support of CPU operations, this estimate does not guarantee or imply that any number of orders will be placed under this ID/IQ award. The actual quantities which will be contracted for with suppliers will be based upon the number of patients who are determined eligible by the VA to receive H-Wave devices. Opportunity amongst the multi-award ID/IQ holders will be provided for by the Government is based upon the demand signal established for H-Wave devices by the Government s prescribing clinicians. It is therefore a material requirement of the ID/IQ that each supplier provide a price list, including the most current information regarding product features in order to furnish the Government s health care providers with information required for them to make the best selection. 1.2 Scope The contractor shall provide all resources necessary to accomplish the deliverables described here in this statement of work and salient characteristics document, except as may otherwise be specified. Contractor shall procure H-Wave H4 Multi-Function Electrical Stimulation Device as identified below in General Requirements, and on the salient characteristics document. Definitions Contract means a mutually binding legal relationship obligating the supplier to furnish the supplies and the Government to pay for them. It includes all types of commitments that obligate the Government to an expenditure of appropriated funds and that, except as otherwise authorized, are made in writing by the Contracting Officer. Contracts include, but are not limited to, orders or bilateral modifications to orders, under which the contract becomes effective by written accept. F.O.B. Destination means Free on Board at Destination, i.e., the supplier delivers the goods on the supplier s conveyance at destination. The supplier is responsible for the cost of shipping and risk of loss. In writing or written means any worded or numbered expression that can be read, reproduced, and later communicated, and includes electronically transmitted and stored information. Latent defect means a defect that exists at the time of acceptance but cannot be discovered by a reasonable inspection. Warranty means a promise or affirmation given by a contractor to the Government regarding the nature, usefulness, or condition of the supplies or performance of services furnished under the contract. Obsolescence means a condition where an item or any critical component is no longer manufactured, supported, or available in a manner that reasonably allows the Contractor to fulfill contract requirements during the contract period of performance and any options. Form, Fit, and Function (FFF) compatible means a replacement item that is physically interchangeable, interfaces identically, and meets or exceeds the performance characteristics and essential features of the specified item without adverse impact to safety, cybersecurity, interoperability, or warranty. Product Change Notice (PCN) means a manufacturer s formal notice of product discontinuation, end of life (EOL), or material design change. 1.3 Objectives This ID/IQ will be a firm fixed price contract with a base year and one option year for the H-Wave H4 Multi-Function Electrical Stimulation Device, or like or similar. The awarded contractor will provide the CPU with devices on a bi-monthly scheduled basis without delay or disruption. 2.0 Requirements/Salient Characteristics The H-Wave H4 Multi-Function Electrical Stimulation Device, part number 41000, will have the minimum characteristics as described below: H-Wave H4 Multi-Function Electrical Stimulation Device 41000 Electrical Nerve Stimulator for Pain Relief Provides H-Wave form treatment which induces not-fatiguing muscle contracts and positively affects nerve function, blood and lymph flow. Battery Rechargeable Ni-MH (7.2 V; 1800 mA/h Battery with charger Channel Two Channels with two sets of lead wires Timer 0 to 60 Minutes Readout Digital LED display with button option selection for frequency selection from 1 to 70Hz Frequency 1 to 70 Hz Dimensions 7" x 4.5" x 1.5 Weight 1.5 to 2 lbs. Consumables Carry case, 2oz aloe gel, 4 packs of electrodes Waveform Multi-phase, variable 2.1 Deliverables Delivery of the H4 Wave devices will be completed on the 1st and 15th of each month. 2.2 Schedule The supplier shall deliver all items ordered under the contract during standard operating hours, Monday through Friday, excluding Federal Holidays, to the following location: Sam Rayburn Memorial Veterans Center CPU Bonham VA Medical Center Attn: Shellman/VISN 17 1201 E. 9th Street Bldg. 10 Bonham, TX 75418 Warehousing The CPU does not have the space available to store the quantity requested on the order and will therefore require the supplier to maintain the device in their warehouse and ship as needed. Responsibilities The contractor shall provide a bi-monthly drop shipment to the CPU. The contractor shall ensure appropriate stock is available to ensure prompt delivery can be made on the 1st and 15th of each month. CPU points of contact shall communicate with the contractor any issues concerning the shipment and delivery of products. Order Placement The contractor shall deliver the requested quantities each month. Product Like or Similar Part Number Bi-Monthly Quantity (1st & 15th) H-Wave H4 home electrotherapy device 41000 75 Replacement Electrodes/ 4 electrodes (2 pairs) A4556 30007 Included Replacement Aloe Gel / 1 bottle A4558 - 2oz bottle 30005 Included The supplier shall maintain sufficient stock and ship the requested quantities to the CPU on a bi-monthly basis. The requested amount shall be shipped to the CPU at no charge to the government or FOB destination. Warranty and Guarantees The supplier shall include its express warranty along with the price list, which is incorporated into the supplier s ID/IQ. The supplier s express warranty or guarantee must protect the Government against any manufacturing, and any other latent defects, for a period of one year or more. During the warranty or guarantees period, the supplier shall make all necessary adjustments resulting from any such defects and agrees to furnish without additional cost to the Government, all labor, and materials necessary to correct defects that were detected during the warrantee or guarantees period at no cost to the Government. The supplier further agrees to replace any defective H-Wave devices through exchange of defective stock for acceptable H-Wave devices at no additional cost to the Government (e.g. shipping, handling, and/or restock fees) Unless otherwise permitted by the supplier s express warranty or guarantee, these conditions do not apply to adjustments incidental to the wearing of eyeglasses, adjustments required by physical change of the wearer, or where there is evidence of deliberate misuse by anyone other than the supplier. Supplier performance, including order fulfillment and quality of materials, will be continuously assessed by the Government. The Supplier Performance Requirements Summary Matrix summarizes supplier performance standards identified throughout the supplier s ID/IQ. The Government shall use this matrix as a rubric to determine whether the supplier s performance falls within an Acceptable Quality Level (AQL) and identifies assessments for supplier performance below the AQL. Obsolescence In the event that the H-Waveform H4 becomes obsolete, the Contractor shall notify the Contracting Officer (CO) in writing within ten (10) business days after becoming aware of any PCN…