Description
DESCRIPTION The Veterans Health Administration (VHA) Non-Expendable Equipment National Program has identified the Neuromuscular Blockade Monitoring product line as a candidate for a VA-wide (otherwise referred to as national ) single Requirements contract award. The Department of Veterans Affairs (DVA) Office of Procurement, Acquisition and Logistics (OPAL) Strategic Acquisition Center (SAC) on behalf of VHA is issuing this Sources Sought Notice in accordance with the FAR 10.002(b)(2) to determine the availability and technical capabilities of qualified sources. The SAC in conjunction with VHA is seeking a qualified source to provide Blink Device TwitchView2® brand name or equal Neuromuscular Blockade Monitoring on an agency wide basis. VA intends to award a Requirements Contract with Firm-Fixed Price (FFP) orders IAW FAR 16.503, Requirements Contract to a supplier of this equipment. Vendors will be required to deliver the Neuromuscular Blockade Monitoring to VA medical centers and facilities throughout the United States and its territories. The anticipated period of performance is for one 12-month base period with four 12-month option periods from the date of award. However, the Government's decision as to whether to continue with the contract, upon annual review, will be based upon successful performance during each previous year and continued need. The Contractor must demonstrate the ability to meet all requirements for the solicitation. The associated North American Industrial Classification System (NAICS) code for this procurement is 334510- Neuromuscular Blockade Monitoring, Product Service Code: 6515 Medical and Surgical Instruments, Equipment, and Supplies and the associated size standard is 1000 employees. The FAR Provision found at 52.204-7(b)(1) requires that All interested Offerors must be registered in SAM.gov prior to submitting an offer or quotation. You may access the website at SAM.gov | Home. All offerors must be certified with the appropriate NAICS code on the SAM website. All SDVOSB/VOSB offerors must be verified in the SBA database at: https://veterans.certify.sba.gov/#search at the time of quote submission. This notice is for planning purposes only and does not constitute a commitment on the part of the Government to award a contract, nor does the Government intend to pay for any information submitted as a result of this notice. This Sources Sought Notice is part of a continuous process for obtaining the latest information on the commercial status of the industry with respect to their current and near-term abilities. The information provided herein is subject to change and in no way binds the Government to solicit for, or award, a competitive contract. It is emphasized that this is a notice solely for planning and informational purposes. 2.0 SCOPE Neuromuscular Blockade Monitoring refers to the process of measuring and assessing the degree of muscle relaxation induced by neuromuscular blocking agents (NMBAs), which are drugs used to induce temporary paralysis, typically during surgical procedures or in intensive care settings. These agents inhibit the transmission of nerve impulses at the neuromuscular junction, leading to muscle relaxation. Monitoring is critical to ensure the appropriate depth of muscle relaxation is achieved and maintained, which helps in optimizing patient safety and the effectiveness of the procedure. Effective neuromuscular blockade monitoring helps in adjusting the dosage of NMBAs, avoiding both underdosing (which may lead to inadequate muscle relaxation) and overdosing (which can result in prolonged paralysis and complications), and ensuring timely and appropriate recovery of muscle function post-procedure. The following Contract Line-Items Number (CLIN) are being considered: Contract Line Items Manufacturer Part Number Description 0001 Blink P-TVSYS-02 TwitchView2 System/ Pole Mount 0002 Blink B-TVSYS-02 TwitchView2 System/ Ball Mount 0003 Blink TVARM-DSL TwitchArm Double Short Long 0004 Blink TVESA03 3-Year TwitchView2 Extended Service Agreement 0005 Blink TVESA05 5-Year TwitchView2 Extended Service Agreement 0006 Blink TVAEA025 TwitchView2 Adult Electrode Array (Case of 25) 0007 Blink TVCAB-02 TwitchView2 Patient Cable 12 FT 0008 Blink TVCAB-03 TwitchView2 Patient Cable 14 FT 0009 Blink TVINSERVICE Clinical In-service Training 1-day 0010 Blink TVST-01 TwitchView2 System Tester 0011 Blink TVCPS-02 TwitchView2 Capsule/Draeger Cable The Department of Veterans Affairs (VA) is seeking vendors who can provide TwitchView2® brand name or equal Neuromuscular Blockade Monitoring as listed above or equal commodities which meets all the following Salient Characteristics (SC): SC # SALIENT CHARACTERISTICS METHOD OF EVALUATION SC 1 The system shall provide electromyography (EMG)-based quantitative neuromuscular monitoring of neuromuscular transmission, measuring both Train-of-Four (TOF) count/ratio and Post-Tetanic Count (PTC) when applicable. Literature Review SC 2 Rechargeable battery with at least 6 hours of use fully charged Literature Review SC 3 Must have single-use patient sensors. The device itself must have written cleaning instructions Literature Review SC 4 Must have capability and required cable to integrate with Anesthesia Record Keeping (ARK) Systems. Literature Review SC 5 Must have noise cancellation that produces clear, diagnostic signal throughout the case, able to filter out interference from surrounding equipment (such as RF interference from electrosurgical unit Literature Review SC 6 User Workflow / Ease-of-Use: The system shall support a simplified workflow: the electrode is placed, Play/Start pressed, and monitoring begins; minimal set-up time to be achieved (e.g., within ~ 20 seconds). Literature Review The Government's intent is to include all ancillary items to ensure the equipment can function as designed by the Original Equipment Manufacturer (OEM) and as clinically required. Vendors are encouraged to provide any product solution or configuration so long as they meet the salient characteristics. Additionally, responses can include any additional product that may be beneficial. These items must be clearly identified by brand name and part number. Responses to this Sources Sought Notice shall include the following: Company information Full name and address of company SAM Unique Entity Identifier (UEI) Business size If authorized distributor, provide evidence that your firm is an authorized distributor for the OEM of the products proposed. Point of contact name and email address Information on your product/solution Does your product have FDA clearance for clinical use in the United States? Please provide a yes or no, with a brief point-by-point explanation of how your product can or cannot meet each draft salient characteristic, in a chart/table format. Please provide OEM technical literature that clearly shows how your product meets each salient characteristic. Please ensure the OEM technical literature is properly mapped with respective page numbers so it is easy to reference and connect to the draft salient characteristics. What are the unique or highlighted features of your neuromuscular blockade monitor specifically, the key physical, functional, or performance characteristics? What are your product solutions or configurations for this anticipated Neuromuscular Blockade Monitoring procurement? Please provide model name(s) and part number(s). What are your product s sensor placement options, and how does it work for amputee patients where standard wrist placement sites may not be an option? Please describe your product s wireless and wired setup. For example, are the sensors wireless or wired? How does your product integrate or communicate with the VA s ARK information system? Can sensors from other brands/manufacturers be used with your product? Or can sensors only from your own brand/OEM be utilized with your product? Are your sensors reusable or single-use only? If disposable, what are the protocols for handling, storage, and disposal? What is your company s ability to provide uninterrupted supply of products on a national scale? What is the country-of-origin designation for your product/solution? Draft salient characteristics/requirements Considering our draft salient characteristics, are there any additional salient characteristics you recommend incorporating, and why? Does vendor offer an annual service plan? If Yes: What does the plan cover? Does plan cover software updates only? Does the plan cover parts repair and/or replacement? Does the plan cover both software and parts? Provide documentation that shows information and details of your service plans. Is the service provided by the OEM or a subcontractor?