SAM #36C10X26Q0066

VA National Contract for Natus EEG and Sleep Monitoring Systems and Services

The Department of Veterans Affairs (VA) is seeking to establish a national contract for EEG and sleep monitoring systems and services to support VA medical centers across the United States. - Government Buyer: - Department of Veterans Affairs (VA), Office of Procurement, Acquisition and Logistics (OPAL), Strategic Acquisition Center (SAC) Frederick - OEM Highlight: - Natus, Inc. is the primary Original Equipment Manufacturer (OEM) specified for all major equipment and software - Products Requested: - EEG/Sleep acquisition desktops, amplifiers, stimulators, monitoring packages, and accessories - SleepWorks and NeuroWorks software, review and nurse station software, and high-resolution video monitoring solutions - Medical-grade UPS units, wall/ceiling mount kits, monitors, and intercom systems - Quantities typically 10 or 40 per item; part numbers such as PK1204HD, PK1274, PK1102, LC101-10, and others - Services Requested: - Installation and training for all systems - Multiple tiers of service coverage (Basic, Flex, Advance) for 1-year and 5-year durations, including on-site support, technical support, maintenance, software updates, and professional services - Notable Requirements: - All equipment must support routine EEG and sleep studies, wireless ambulatory monitoring, simultaneous video/audio data collection, and continuous recording - Minimum 32-channel capability, electromagnetic emissions compliance, FDA or 501(K) approval - Extended warranty and training included - Delivery and Performance: - Equipment and services to be delivered and performed at VA medical centers and facilities nationwide - Contract includes a 12-month base period with four 12-month option periods

Description

1.0 DESCRIPTION The Veterans Health Administration (VHA) Non-Expendable Equipment National Program has identified the Electroencephalography (EEG): Electroencephalographic product line as a candidate for the Department of Veterans Affairs (VA)-wide (otherwise referred to as national) Non-Expendable Equipment (NX) Requirements contract award. The Department of Veterans Affairs (VA) Office of Procurement, Acquisition and Logistics (OPAL) Strategic Acquisition Center (SAC) on behalf of VHA is issuing this Sources Sought in accordance with Revolutionary FAR Overhaul (RFO) 10.001 to determine the availability and technical capabilities of qualified sources. The SAC in conjunction with VHA is seeking a qualified source to provide Natus Electroencephalography (EEG): Electroencephalographic systems and components on an agency-wide basis. VA intends to award a Requirements Contract with Firm-Fixed Price (FFP) orders IAW RFO 16.503, Requirements Contract to a supplier of this equipment. Vendors will be required to deliver Electroencephalography (EEG): Electroencephalographic systems and components to VA medical centers and facilities throughout the United States. 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 or not 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 334510 - Electromedical and Electrotherapeutic Apparatus Manufacturing and the associated size standard is 1,250 employees. The RFO Provision found at 52.204-7 requires that The Offeror shall have an active Federal Government contracts registration in the System for Award Management (SAM) when submitting an offer or quotation in response to this solicitation and at the time of award. You may access the SAM website at Home | SAM.gov. All offerors must be certified with the appropriate NAICS code on the SAM website. All SDVOSB/VOSB offerors must be verified in the Small Business Administration (SBA) database at Veteran Small Business Certification (VetCert) database at: Veteran Small Business Certification (sba.gov) at the time of proposal 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 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 Electroencephalography uses electrodes placed on a patient's scalp to measure, amplify, filter, and record the electrical signals (EEG signals) generated by the brain and subsequently display the acquired patient data in digital wave forms. There are three Neurodiagnostic procedures that Electroencephalographic systems are used for: Electroencephalography (EEG), Intraoperative Monitoring (IONM), and Long-Term Monitoring (LTM). The first Neurodiagnostic procedure, EEG, is used in areas such as Outpatient Labs, Inpatient Wards, and ICU settings. It observes and diagnoses a range of neurologic conditions, including epilepsy. It can also be employed to evaluate psychiatric disorders and differentiate them from neurologic conditions. IONM has the capability to monitor the functional integrity of neural structures during surgeries such as Carotid Endarterectomy, Corticography, Brain Mapping, Stimulation, Aneurysm Clipping, and the effects of anesthesia on the brain during these procedures. LTM is the collection of EEG data over a period of time. These recordings include Ambulatory EEG (aEEG), which is used for recording at the Veteran's residence. Continuous EEG (cEEG) is used for inpatient video monitoring greater than 2 hours. Prolonged EEG (pEEG) monitoring is used for outpatient video monitoring greater than 2 hours. Video EEG (vEEG) is an elective EEG admission for prolonged video EEG recording which is performed in an Epilepsy Monitoring Unit (EMU). An EMU is a specialized inpatient unit designed to evaluate, diagnose, and treat seizures. The ability to record and monitor non-invasive scalp electrode EEG, intracranial EEG (Grid and Strip), and invasive stereotactic depth electrodes (sEEG) is the gold standard using state-of-the-art continuous video electroencephalogram (vEEG) monitoring technology.

The following Contract Line Items are being considered: Contract Line Items Manufacturer Part Number Description Base Year Option Year 1 Option Year 2 Option Year 3 Option Year 4 0001NATUS INCPK1204HDEEG/Sleep Acq Desktop with IP PTZ 1080p HD Color/BW Camera on ErgoJust Cart1010101010 0002NATUS INCUPS-NA-EJMedical Grade UPS with Isolation - 110V ErqoJust Cart1010101010 0003NATUS INCPK1274Natus Brain Monitor Amplifier1010101010 0004NATUS INCPK1102LED Photic Stimulator.1010101010 0005NATUS INC23431Natus Brain Monitor BB Holster/Arm Cart Kit1010101010 0006NATUS INCAMB-MON- VIDWIFl-10Ambulatory Monitoring Package with Tablet, Software NW 10, Single IP Wi-Fi Camera Kit - 111010101010 0007NATUS INCPK1108T-FHDEEG/Sleep Tech Room Acquisition Desktop with Ceiling Mount 1080p HD IP PTZ Camera1010101010 0008NATUS INCUPS-NAMedical Grade UPS with Isolation (North America 5-15R HG pluQ)1010101010 0009NATUS INCPK1072-NTB-9EMU40EX with new Natus Base (Requires NW 9.x or newer)1010101010 0010NATUS INC10368EMU40 / Brain Monitor Wall Mount Kit1010101010 0011NATUS INCPK1058Small-form Factor Computer (NeuroWorks/SleepWorks not Included)1010101010 0012NATUS INCLC105-10NeuroWorks 10.x Nurse Station Software1010101010 0013NATUS INCPK1014Review/Monitoring Desktop (NeuroWorks software not included)1010101010 0014 LC102-10NeuroWorks 10.x Review Software      0015NATUS INCPK1103LED Photic Stimulator with Stand1010101010 0016NATUS INCPSG-WALL- PTZHD-SDX-10PTZ Video, SDx amp, SleepWorks 10, no Sensor Kit SleepWorks Sys with Wall Mounted 1080p1010101010 0017NATUS INCPSG-CEIL-PTZHD- SDX-10SleepWorks System with Ceiling Mounted1080p PTZ Video,SDx amp, SleepWorks 10, no Sensor Kit1010101010 0018NATUS INCPSG-WALL-PTZ- FHD-NDX-10SleepWorks system Wall mount 1080p PTZ, Embla NDx, PC, 24" LCD, SleepWorks V10.x, Rpt Ed.1010101010 0019NATUS INCPSG-CEIL-PTZ- FHD-NDX-10SleepWorks system Ceiling mount 1080p PTZ, Embla NDx, PC, 24" LCD, SleepWorks V10.x, Rpt Ed1010101010 0020NATUS INC2929Persyst Continuous/ Long-term Monitoring (Persyste)1010101010 0021NATUS INC105075XL24in FP Monitor4040404040 0022NATUS INCLC101-10NeuroWorks 10.x Acquisition Software with Spike / Event and High Res Video4040404040 0023NATUS INCREPORT-EDITORMS Word Report Editor for Neuroworks/Sleepworks1010101010 0024NATUS INC10193Extended Video Monitoring Controllers3030303030 0025NATUS INCNO-ISOIsolation Transformer Not Included.3030303030 0026NATUS INC24252Sleep Supplies Starter Kit with Single Use Supplies for Embla DX Series Amplifiers1010101010 0027NATUS INCSVC808BM01Xitek BioMed Trg @natus1010101010 0028NATUS INC48354Logitech Wireless Keyboard and mouse for Trex HDM Case (English)4040404040 0029NATUS INC48355Hand Cart for Trex HDM Ez-Case1010101010 0030NATUS INC4244014Prem Intercom Sys W/Recording1010101010 0031NATUS INC015968Star Tech Pcle Gigabit NIC1010101010 0032NATUS INCSVC800INSTALl_INCInstallation Included4040404040 0033NATUS INCSVC800TRAIN_INCTraining Included4040404040 0034NATUS INCEEG Monitoring System 1 year Basic Care Service Coverage Benefits. Coverage Dates: TBD (1 year after installation).1 year only, Billable On Site Support - Labor, Travel & expenses, Priority Technical Support Phone Queue with PIN Access, Service Parts Replacement/Repair Including and Overnight Shipping on Part(s) In Stock - Loaner Provided if Required, Performance/Maintenance Check with Inventory Verification Upon Customer Request, Software Updates Upon Customer Request (When Available), and Billable Professional Services (Remote Support Only). All options excludes Persyst Software Assurance Agreement. HL7 is remote support only. Coverage does not include modifications to the interface.1010101010 <!-- Additional rows omitted for brevity -->

The Department of Veterans Affairs (VA) is seeking vendors who can provide the Steris Corporation V-Pro Max 2 Sterilizer or equal as listed above which meet all the following salient characteristics:

Contract Line Items and Salient Characteristics Mapping CLIN's 0001 to 00031 apply to SC's 1-10, SC 12, and SC 14 CLIN's 0034-0057 apply to SC 11 CLIN 0033 applies to SC 13

Salient Characteristics (SC) and Method of Evaluation SC #SALIENT CHARACTERISTICSMETHOD OF EVALUATION SC 1Must have the capability to perform EEG (Routine) assessments by acquiring and recording data.Literature Review SC 2EEG system must have a fully wireless in-home care (Ambulatory) configuration optionLiterature Review SC 3Must have the polysomnography (PSG) package option to perform a full sleep studyLiterature Review SC 4Must have EEG analysis softwareLiterature Review SC 5Must have Seizure and Spike/Burst DetectionLiterature Review SC 6Must be able to simultaneously collect video and audio data during EEG data collectionLiterature Review SC 7Must have Remote viewing capabilitiesLiterature Review SC 8EEG must have continuous audio and video (with infrared) data recording capability for assessments greater than two hours (Long Term)Literature Review SC 9Must have a minimum of 32 channelsLiterature Review SC 10Must be Electromagnetic Emissions IEC 60601-2 compliantLiterature Review SC 11Must provide extended service and support plan option.Literature Review SC 12Must have minimum one-year WarrantyLiterature Review SC 13Must provide training.Literature Review SC 14FDA or 501(K) approvedLiterature Review

For each product (brand name and part number), the response must include descriptive literature demonstrating the product meets or exceeds the SCs 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 and as clinically required. Vendors are encouraged to provide any product solution or configuration so long as they meet the SCs. 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: Full name and address of company; Unique Entity Identifier (UEI) number; Business Size; Manufacturer or Distributor; If distributor provide full name, business size and address of manufacturer. Country of Origin designation for all products; Ability to provide uninterrupted supply of products on a national scale; Technical Literature that clearly shows product(s) meet the identified SCs (if submitting an "or-equal" item); Any additional product solution or configuration that would be beneficial to the clinical functionality of the product line identified. Although not required, vendors responding to this Sources Sought may also submit a Capabilities Statement. Contractors submitting capability statements in response to this RFI must specifically address the questions outlined above. Generic capability statements that do not directly pertain to this RFI will not be considered. Additionally, links requesting capability statements or further information will not be accessed. All responses must be submitted as an actual file attachment.

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