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, EOL, or obsolescence condition that may affect the ability to deliver the item, spares, accessories, consumables, software/firmware, or maintenance services under this contract. The notice shall include: (i) the affected manufacturer part number(s), model(s), serial/lot applicability; (ii) last time buy date(s) and quantities; (iii) the proposed replacement item(s) with full technical description; (iv) impact to interfaces, dimensions, performance, safety/cybersecurity certifications, and maintenance/warranty; and (v) proposed schedule and transition plan. Replacement Item Requirements The Contractor shall propose a replacement that is FFF compatible and that meets or exceeds the salient characteristics/specifications in the PWS. If exact FFF compatibility is not feasible, the Contractor shall identify all deviations and any required installation changes, adapters, cables, software/firmware updates, training, or documentation. Replacement items shall be new (not refurbished), from an authorized manufacturer/authorized distributor, and maintain equal or better warranty coverage, parts availability, and service support. For items with software/firmware, the Contractor shall ensure the replacement is compatible with existing configurations and complies with applicable cybersecurity requirements (e.g., FIPS/VA cybersecurity controls as specified in Section C), and shall provide any required updates at no additional cost unless otherwise approved by the CO. Government Approval Prior to Substitution The Contractor shall not substitute any item without prior written approval from the CO. Unauthorized substitutions may be rejected at the Contractor s expense. The Government will review the Contractor s proposal and notify the Contractor of approval or disapproval within thirty (30) calendar days, or such other period as agreed in writing. Pricing and Adjustments Unless otherwise agreed, the unit price of an approved replacement item shall not exceed the contract unit price for the original item. If the proposed replacement increases cost, the Contractor shall provide adequate price justification (e.g., catalog pricing, commercial sales data, or other cost/price information consistent with FAR Part 12/15, as applicable). Any price increase requires a bilateral modification. Any cost decreases associated with technology refresh or replacement shall be passed through to the Government via equitable price reduction. Requirement Acceptable Quality Level Method of Surveillance Assessment for Supplier Failing to Maintain AQL The supplier shall provide all H-Wave devices ordered under the contract in strict conformance to the ID/IQ and order sheet provided by the Government as a part of the order and resulting contract. 100% Monitored continuously through the routine H-Wave devices ordering process. -Total or partial termination for cause of contract;

• 10% Reduction of payment for all remaining invoices for contract;
• Supplier adverse past performance recorded;
• Opportunity will not be provided to supplier for future orders;
• Potential cancellation of supplier s ID/IQ.

The supplier shall notify the CO immediately of product recalls, removal, required adjustment, or modification within required timelines. 100% Monitored continually through oversight.

• Supplier adverse past performance recorded;
• Opportunity will not be provided to supplier for future orders;
• Potential cancellation of supplier s ID/IQ.

2.3 Hours of Operation Delivery shall be performed during normal working hours from 8:00 am to 3:30 pm excluding federal holidays unless requested and approved by the COR. Federal holidays include: New Years' Day Martin Luther King Jr. Day Presidents' Day Memorial Day Juneteenth Independence Day Labor Day Columbus Day Veterans Day Thanksgiving Day Christmas Day When a holiday falls on a Sunday, the following Monday shall be observed as a legal holiday. When a holiday falls on a Saturday, the preceding Friday is observed as a legal holiday by U.S. Government agencies. Also, included, would be any other day specifically declared by the President of the United States of America to be a National Holiday. 3.0 Invoicing and Billing: In 2007 the Department of Veterans Affairs (VA) entered a relationship with Tungsten Network. With Tungsten Network, all Department of Veterans Affairs suppliers will now be able to securely submit invoices directly from their existing invoicing formats. In addition, by submitting invoices electronically through Tungsten Network, Department of Veterans Affairs suppliers will experience prompt payment with reduced exceptions. An itemized invoice shall accompany each filled order from the contractor. This invoice must include invoice number, VA Obligation Number (Task Order number), ordering PO number, Order Date, Ship Date, Description of items, and show quantities of each item ordered, shipped, and backordered, as well as item cost, extended cost, and invoice total cost. The itemized billing invoices will be submitted to the VA Financial Services Center (VAFSC) for payment through Tungsten Network for payment no later than 10 working days after each month of service. Billing invoices can be submitted sooner if desired by the Contractor. All invoices will be submitted in accordance with these instructions. Your participation in this existing process is required to continue providing products or services to the Department of Veterans Affairs in compliance with the Improper Payments Elimination and Recovery Act of 2010 (IPERA) and mandate AN97. The rule mandating electronic invoice submission was published on November 27th, 2012, and has an effective date of December 27th, 2012. Mandate AN97 can be located on the Federal Registry at https://www.federalregister.gov/documents/2012/11/27/2012-28612/va-acquisition-regulation-electronic-submission-of-payment-requests. Suppliers may comply with the mandate by using either of the two methods below: The FSC uses a third-party contractor, Tungsten Network, for electronic invoice submission. For information on Tungsten Network electronic invoicing set-up, suppliers should call 866-340-4980 or email http://www.tungsten-network.com/veteransaffairs/ . A system that conforms to the X12 electronic data interchange (EDI) format established by the Accredited Standards Center. For FSC e-Invoicing information, please call 877-353-9791 or email vafsccshd@va.gov . Verification of orders and delivery to the Government shall be documented and provided to the COR during each billing cycle. The supplier shall provide a list of materials, quantities, and prices, as well as proof of shipment and delivery of H-Wave devices, as a material part of its proper invoice. The Government may dispute a charge if an invoice and/or the product has not been received. If Government disputes a charge, the invoice may be rejected, or that charge will be deducted from the invoice amount to be paid and the supplier notified accordingly Any billing discrepancies shall be addressed by the Government to the supplier for resolution within 15 days from receipt of the comprehensive bill. It is permissible under the terms and conditions of the ID/IQ for the supplier and Government to process payments via the Government Purchase Card (GPC), should the Tungsten billing method be unavailable. In order for the supplier to be eligible for a GPC payment, the supplier shall be Level II billing capable and able to accept the credit card for payment. If this involves additional equipment, computers, or surcharge, this shall be at the supplier s expense. The Government issued purchase order number shall be inserted in the supplier s order information block. In the event of a GPC payment, a credit card receipt with the invoice and signed acceptance receipt shall be forwarded by the supplier to the cardholder who placed the order as soon as the transaction has been completed. 4.0 Information Security and Privacy The C&A requirements do not apply, and a Security Accreditation Package is not required. Contractor will not access the VA Network. 5.0 Records i. Citations to pertinent laws, codes, and regulations such as 44 U.S.C chapters 21, 29, 31 and 33; Freedom of Information Act (5 U.S.C. 552); Privacy Act (5 U.S.C. 552a); 36 CFR Part 1222 and Part 1228. ii. Contractor shall treat all deliverables under the contract as the property of the U.S. Government for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. iii. Contractor shall not create or maintain any records that are not specifically tied to or authorized by the contract using Government IT equipment and/or Government records. iv. Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected by the Freedom of Information Act. v. Contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the contract. vi. The Government Agency owns the rights to all data/records produced as part of this contract. vii. The Government Agency owns the rights to all electronic information (electronic data, electronic information systems, electronic databases, etc.) and all supporting documentation created as part of this contract. Contractor must deliver sufficient technical documentation with all data deliverables to permit the agency to use data. viii. Contractor agrees to comply with Federal and Agency records management policies, including those policies associated with the safeguarding of records covered by the Privacy Act of 1974. These policies include the preservation of all records created or received regardless of format [paper, electronic, etc.] or mode of transmission [email, fac, etc.] or state of completions [draft, final, etc.] ix. No disposition of documents will be allowed without the prior written consent of the Contracting Officer. The Agency and its contractors are responsible for preventing the alienation of unauthorized destruction of records, including all forms of mutilation. Willful and unlawful destruction, damage, or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S. C. 2701. Records may not be removed from the legal custody of the Agency or destroyed without regard to the provisions of the Agency records schedules. x. Contractor is required to obtain the contracting officer s approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring …