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Sources Sought Notice Sources Sought Notice Page 6 of 6 Sources Sought Notice *= Required Field Sources Sought Notice Page 1 of 6 REQUEST FOR INFORMATION 1.0 DESCRIPTION The Veterans Health Administra... Sources Sought Notice Sources Sought Notice Page 6 of 6 Sources Sought Notice *= Required Field Sources Sought Notice Page 1 of 6 REQUEST FOR INFORMATION 1.0 DESCRIPTION The Veterans Health Administration (VHA) Non-Expendable Equipment National Program has identified the Cardiopulmonary Diagnostic Systems 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 Request for Information (RFI) under the FAR 10.002(b)(2) to determine the availability and technical capabilities of qualified sources. The period of performance will consist of a base of 12 months with four 12-month option periods from the date of award. The SAC in conjunction with VHA is seeking a qualified source to manufacture Cardiopulmonary Diagnostic Systems on an agency-wide basis. VA intends to award a Brand Name or Equal (BNOE) single award Requirements contract for this requirement IAW with FAR 16.503. Vendors will be required to deliver Cardiopulmonary Diagnostic Systems to VA medical centers and facilities throughout the United States. The associated North American Industrial Classification System (NAICS) code for this procurement is 339112 Surgical and Medical Instrument Manufacturing, 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 before submitting an offer or quotation. You may access the SAM website at https://www.sam.gov/portal/public/SAM/. All offerors must be certified with the appropriate NAICS code on the SAM website. All SDVOSB/VOSB offerors must be verified in the Vendor Information Pages (VIP) database at: https://www.vip.vetbiz.va.gov/ at the time of offer submission. This notice is for planning purposes only and does not constitute a commitment on the part of the Government to award a Requirements contract, nor does the Government intend to pay for any information submitted because of this notice. This RFI is part of a continuous process for obtaining the latest information on the commercial status of the industry concerning 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 Cardiopulmonary Diagnostic Systems are a diagnostic modality used to evaluate a patient's functional capacity. Cardiopulmonary Diagnostic Systems can identify cardiac or pulmonary disease in patients with marginally abnormal diagnostics or in those who appear more clinically disabled than their diagnostic tests indicate. Collected data allows the clinician to assess a patient s overall cardiopulmonary function. This can be useful in pre-operative risk assessment, the diagnosis of various cardiopulmonary diseases, the evaluation of post-operative recovery, or a more general assessment of an individual s exercise capacity. The test can provide a wealth of knowledge about both cardiac and pulmonary disease processes, while also aiding in the development of individualized therapy and rehabilitation programs. Cardiopulmonary Diagnostic Systems are used to assess respiratory performance in patients with suspected pulmonary disease, often after simple spirometry testing has identified a potential problem or in the presence of specific symptoms. By measuring a variety of different parameters, Cardiopulmonary Diagnostic Systems can provide a comprehensive assessment of a patient's respiratory status (e.g., effectiveness of ventilation, gas diffusion, airway resistance, etc.). Body plethysmography is a noninvasive type of lung function testing known as a pulmonary function test. It can help determine how much air is in your lungs after you take a deep breath in (inhale). It also helps determine how much air remains in your lungs after you take a deep breath out (exhale). Test results aid in determining baseline ventilatory function, the type and degree of impairment (if any), and the effectiveness of subsequent therapy. This requirement will be IAW FAR clause 52.211-6, Brand Name or Equal which requires the Offeror to indicate that each product being offered is an equal product to the Vyaire® Cardiopulmonary Diagnostic Systems. 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 Offeror must also clearly identify the item by brand name (if any) and make/model number. Finally, the Offeror 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. The Contract Line Items (see Attachment 1 CARDIOPULMONARY DIAGNOSTIC SYSTEM CLINs Structure) will be awarded in the proposed BRAND NAME OR EQUAL (BNOE) SINGLE AWARD REQUIREMENTS CONTRACT. The Department of Veterans Affairs (VA) is seeking vendors who can provide Vyaire® Cardiopulmonary Diagnostic Systems or equal as listed above which meet all the following salient characteristics: Vendors may quote any product solution or configuration so long as they meet the salient characteristics. Products quoted in the technical volume must be captured on the Vendor s pricing volume (Attachment A, Price Cost Schedule) of the solicitation. Vendors may quote any additional ancillary products that they deem to be essential to the functionality of the proposed solution; these items must be captured in the Vendor s pricing volume with a quantity of zero. SC # CLINS Salient Characteristics Method Of Evaluation Page Number SC 1 0001, 0006, 0011, 0015-0018, 0025. 0029 and 0035 The system shall be able to perform PFT (Pulmonary Function Testing) and/or CPET (Cardiopulmonary Exercise Testing)/gas exchange testing. Literature Review SC 2 0001, 0006, 0011, 0015-0018, 0025. 0029 and 0035 The system shall be able to measure spirometry (FVC, SVC, MVV) testing and bronchial challenge/provocation testing. Literature Review SC 3 0001, 0006, 0011, 0015-0018, 0025. 0029 and 0035 The system shall have the ability to create/design customizable reports. Literature Review SC 4 0001, 0006, 0011, 0015-0018, 0025. 0029 and 0035 The system shall meet, at a minimum, ATS (American Thoracic Society) standards. Literature Review SC 5 0029 and 0035 The system must be able to perform: Diffusion Capacity/DLCO MIP/MEP Literature Review SC 6 0018 and 0025 The system must be able to perform: CPET/Exercise Capacity (O2 and CO2) REE, breath by breath ECG Literature Review SC 7 0049 The system shall have the ability to interface with the VA national platform for PFT interpretation (currently Somnoware). Literature Review Responses to this Sources Sought Notice shall include the following: Full name and address of the company DUNS number/ CAGE Code/ SAM UIE Business Size Manufacturer or Distributor If the distributor provides the full name, business size, and address of the manufacturer. Country of Origin designation for all products Ability to provide an uninterrupted supply of products on a national scale. Technical Literature that clearly shows the product(s) meet the identified salient characteristics (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. Fill out Attachment 2 VA HANDBOOK 6500.6 and return it. Although not required, vendors responding to this Sources Sought may also submit a Capabilities Statement.