6515--PHYSIOLOGIC MONITOR MODULES: EEG (SEDATION MONITOR) (VA-26-00042266)

1. DESCRIPTION The Veterans Health Administration (VHA) Non-Expendable Equipment National Program has identified SedLine® Electroencephalogram (EEG) monitors 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 10.001(b) to determine the availability and technical capabilities of qualified sources. The SAC in conjunction with VHA is seeking a qualified source to provide SedLine brand name or equal for the SedLine® Electroencephalogram (EEG) based sedation monitor 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 SedLine® Electroencephalogram (EEG) based sedation monitor to VA medical centers and facilities throughout the United States and its territories. The anticipated period of performance is for one (1) 12-month base period with four (4) 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 associated North American Industrial Classification System (NAICS) code for this procurement is 339112 - Surgical Appliance and Supplies Manufacturing, Product Service Code: 6515 Medical and Surgical Instruments, Equipment, and Supplies and the associated size standard is 1,000 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. SCOPE OF WORK: The Veterans Health Administration (VHA) Non-Expendable Equipment National Program has identified the SedLine® Electroencephalogram (EEG) based sedation monitor product line as a candidate for a VA-wide (otherwise referred to as national ) Requirements contract. In Veterans Affairs Medical Data Needs System (VAMDNS), this equipment category is defined as follows: modules designed to be used as a component of a physiologic monitor, along with related devices, to acquire, measure, and process information for the purpose of continuously monitoring electrical signals generated by the brain and the associated electroencephalogram (EEG). These modules contain electronic circuits or other technology designed to acquire and/or process a signal from one or more physiologic sensors (e.g., electrodes) and transmit it to the physiologic monitor, which contains the software designed to support the module's intended function(s). Electroencephalography monitor modules must be inserted in a dedicated location (e.g., ""slot"") within a physiologic monitor (e.g., modular or modular/configured bedside or transport monitor) or related device (e.g., module rack) in order to support the desired function(s). Typically, EEG measurements/trends are monitored via electrodes placed on a patient's scalp and/or forehead; intracranial (e.g., subdural, epidural) and nasopharyngeal sites are sometimes used. Electroencephalography module functions include display of numeric values/trends for EEG measurements and associated waveforms and appropriate initiation of visual/audible alarms. Electroencephalography modules may support a variety of signal-processing and display techniques (e.g., compressed spectral array, density spectral array, bispectral analysis), depending on the application (e.g., monitoring of intensive care patients, level-of-consciousness monitoring of anesthetized patients). An example of a specialized technique for level-of-consciousness monitoring is bispectral analysis, a signal-processing technique that quantifies the degree of phase coupling between the sinusoidal components of the EEG signal and produces an index from EEG data to correlate with the degree of awareness of anesthetized patients. 3. REQUIREMENT This requirement will be solicited and awarded as a Brand Name or Equal which requires the quoter indicate that each product being offered as an equal product to the SedLine® brand name or equal for the SedLine® Electroencephalogram (EEG) based sedation monitor For each equal product, the offeror must include a description reflecting the salient characteristics (SC) and level of quality that will satisfy the salient physical, functional, or performance characteristics of the equal product(s) specified in the solicitation. The vendor must also clearly identify the item by brand name (if any) and make/model number. Finally, the vendor must include descriptive literature, such as illustrations, drawings, or a clear reference to previously furnished descriptive data or information available to the Contracting Officer and clearly describe any modifications it plans to make to a product to make it conform to the solicitation requirements. Contract Line Items Manufacturer Part Number Description 0001 Masimo 9515 KIT, ROOT, MASIMO, 1/BX 0002 Masimo 4248 RD SEDLINE EEG SENSOR, 25/BX 0003 Masimo 9513 SEDLINE KIT (MOC-9 MODULE AND PATIENT CABLE), 1/BX The Department of Veterans Affairs (VA) is seeking vendors who can provide Masimo SedLine® as listed below which meet all the following Salient Characteristics (SC). CLINs 0001 0003 apply to the following: SC# Salient Characteristics Method of Evaluation Literature Mapping SC 1 System must provide processed Electroencephalogram (EEG) Index Literature Brochure, Brain Monitoring Differentiation, US (PLM-11917C ) (2) Page 3 SC 2 System must provide four channels of continuous raw EEG Literature Brochure, Next Generation SedLine (PS-60586) (PLM-11107B) (2) Page 4 SC 3 System must provide bilateral Density Spectral Array (DSA) Literature Brochure, Next Generation SedLine (PS-60586) (PLM-11107B) (2) Page 1 SC 4 The system must provide and display the following monitoring parameters on a single platform: SC#1 processed EEG index, SC#2 raw EEG, and SC#3 bilateral DSA Literature Brochure, Next Generation SedLine (PS-60586) (PLM-11107B) (2) Page 1 CLINs MANUFACTURERS PART NUMBERS DESCRIPTION BASE YEAR OPTION YEAR ONE OPTION YEAR TWO OPTION YEAR THREE OPTION YEAR FOUR 0001    30 30 30 30 30 0002    30 30 30 30 30 0003    30 30 30 30 30 Design Design features and functions of the offered device will be evaluated for its ability to aid in the performance of its intended function. Areas include but are not limited to the following: Ability to integrate with other Surgical Equipment Probe functions/versatility Customization for various procedures (options) Irrigation options/availability Number and variety of input/outputs connection/ports for peripheral devices Types of procedures supported Performance The Device will be evaluated for its ability to perform its intended function. Areas included but are not limited to: Touch Screen features and ease of use Workflow performance of complete system Types/modes of energy (above and beyond what is in the SCs) Power adjustability Safety The device will be assessed for patient safety features, including, but not limited to, the following areas: Audible tones and visual alarms Contact monitoring data display Quality/Service /Training Training - Availability and options Service - Terms and conditions Warranty Terms and conditions Again, for each product (brand name and part number), the response must include descriptive literature demonstrating the product meets or exceeds the salient characteristics specified above. 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: 1. 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. 2. 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. Does vendor offer an annual service plan, Yes or No? 3. If Yes: What does the plan cover? Does plan cover software updates only? Does the plan cover parts repair or replacement only? Does the plan cover both software and parts? 4. Vendors are requested to provide documentation that shows information on their service plan. 5. Is the service provided by the OEM or a subcontractor? 6. Full name and address of company 7. DUNS number/ CAGE Code/ SAM UIE 8. Business Size 9. Manufacturer or Distributor: If distributor - provide full name, business size and address of manufacturer. 10. Country of Origin designation for all products 11. Ability to provide uninterrupted supply of products on a national scale. 12. Technical Literature that clearly shows product(s) meets the identified salient characteristics and page numbers where each salient characteristic is met. 13. Any additional product solution or configuration that would be beneficial to the clinical functionality of the product line identified. 14. Authorized Distributor Letter Certified by OEM with a current date. Although not required, vendors responding to this Sources Sought may also submit a Capabilities Statement.