Statement of Work Statement of Work (SOW) For Brand Name or Equal to MGC Diagnostics Platinum Elite DX Department of Veterans Affairs Wilmington VA Medical Center 1601 Kirkwood Highway Wilmington, DE 19805-4917 Introduction of Required Specifications: Purpose: The current PFT machine and servers are approaching 10 years of service and will exceed the current warranty. This will place them at the end of their life cycle. In addition, the operating systems on the servers are no longer supported. This creates a possible security risk. Lastly, the new system will communicate with patient record and more studies to patient chart automatically. This will streamline the data movement process and ensure that we meet the national standard for capturing and storing studies. This Statement of Work (SOW) is to outline the tasks and responsibilities of the awarded contractor in relation to provisions, installation, integration and implementation to upgrade the current ventilation system at the Wilmington VAMC, Wilmington, DE. The Contractor must provide all necessary tools, equipment/hardware, software, licenses, installation, maintenance, warranty and training in accordance with this SOW. Primary Goals: This procurement will upgrade the existing ventilation equipment currently in place to at the facility. The current equipment will exceed the life cycle by the end of the fiscal year. This replacement will improve patient care and safety as well as provide a consistent and reliable end user experience at point of care and communicate with the current EMR. Equipment: All equipment must be BRAND NAME or EQUAL to MGC Diagnostics Platinum Elite DX, state of the art, and not recertified nor refurbished. All equipment must be compliant with current facility requirements for allowable operating system platforms. Industry Standards: Unless otherwise stated, all equipment must be held to current industry standards for such equipment as present within the current market for ventilation equipment, supplies, and related services. Contractor must meet all minimum requirements contained in this SOW. Definitions: Platinum Elite DX is a body plethysmograph system, which used for diagnosis and monitoring of a patient lung function. Clinical acceptance: This system will be used for diagnosis and monitoring of COPD, cardiac, and burning pit patients. Equipment Minimum Requirements: Plethysmograph system must Perform testing for Pre/post FVC, SVC, MVV, TGV, RAW, DLCO, Nitrogen washout, MIP/MEP respiratory Mechanics and FVC challenge (with optional bronchial provocation software) Cardiorespiratory diagnostic software, (ex. BreezeSuite) Include predicted formulas (ex. NHANES III & Global Lung Initiative) Network capable to be added to a local or wide area network Trend reports Multi-user option Electronic signature option Installation Considerations: 1.4.1 There is no installation included in this SOW. 1.4.2 Remote Access: The contractor will ensure they understand and implement the IT security requirements for system interconnection documents required per the Memorandum of Understanding or Interconnection Agreement (MOU-ISA). The standard operating procedure (SOP) and a template for a MOU-ISA are located on the Information Protection Risk Management (IPRM) Portal and can be provided to the contractor. The facility will work with the contractor to establish a MOU-ISA for this requirement/equipment. 1.4.3 Facility is responsible for sponsoring vendors remote access, background checks, and/or security access necessary to enable remote access for the vendor. 1.4.4 If power is needed it is the hospitals responsibility to pull the power. 1.4.5 Any mounting required is the responsibility of the hospital. 1.4.6 Contractor must comply with all facility mandated and local permitted/safety requirements. 1.4.7 Contractor will dispose of all boxes, trash and debris resulting from installation IAW hospital policy. 1.4.8 Facility will sponsor and submit necessary paperwork thru appropriate channels in order for equipment contained in this contract to obtain TRM and/or RMF and/or any other necessary cybersecurity approvals. 1.4.9 Delivery of equipment will be NLT 120 days ARO. 1.4.10 Installation of equipment and/or clinical training will be NLT five business days after delivery of equipment. Support Features: 1.5.1 Clinical Training: This is a standalone system which requires minimal clinical training that should be accomplished in a day. 1.5.2 Telephone Support: Must include 24x7x365 Unlimited Telephone Support, 24x7 Go-Live Clinical Support by Telephone per Department, 24x7 Ongoing Clinical Support by Telephone per Department for the life of the system. This support must be at no additional cost to the Government. 1.5.3 There is no maintenance and/or service-related costs included in this SOW for equipment. That will need to be purchased on a separate contract. 1.6 Warranty: 1.6.1 Equipment Warranty: The equipment contained in this contract must come with a minimum 1-year warranty. 1.6.2 Third Party Product Warranty: Third party products come with a standard 1-year warranty that starts at the time of installation. After this time period the hospital is responsible for maintenance of these items with the OEM. 1.6.3 Supply and Accessory Warranty/Restocking Fee: Customer can return equipment within 30 days of purchase with 0% restocking fee if returned in unopened, original packaging. Equipment returned within 30 days to six-months in unopened, original packaging is subject to a 20% restocking fee. Equipment returned after six months will not be accepted. 1.7 Exclusions: 1.7.1 Asbestos testing or abatement is not the responsibility of the Contractor. 1.7.2 The contractor will not work in a bio-hazardous, radioactive, toxic, or other high-risk environment. 1.7.3 The Contractor will not provide structural, mechanical, conduit installation or electrical drawings. 1.7.4 The facility is responsible for hanging any devises on the wall/ceiling that require drilling behind sheetrock. 1.7.5 The facility is responsible to repair-patch and/or paint any walls or ceilings effected by installation or deinstallation of equipment. 1.7.6 The facility is responsible for any new network or cabling required for the installation of the system. 1.7.7 Facility is responsible for deinstallation/disposal of current Government-owned equipment, if applicable. Product Information: 1 - Platinum Elite DX Body Plethysmograph with RTD, 726 Liter Plethysmograph Chamber with Spirometry, Thoracic Gas Volumes, Airways Resistance, Nitrogen Washout & Real Time Diffusion Capacity Includes: BreezeSuite Software, Windows Computer, 3L Syringe, Startup Kit, Regulators for O2, DLCO & Calibration Gas, & One E Cylinder of Calibration Gas **Customer Must Provide H/K Tanks of O2 & DLCO Gas** - Ergotron Cart with LCD Pivot 1 - Environment Monitor, Includes: Environment Monitor (temp, humidity and pressure) & Interface Cable 1 - Bronchial Provocation, Bronchial Provocation Software Option for Platinum Elite 1 - Pulmonary Consult, Pulmonary Consult Software Option for Platinum Elite 1 - Query Database, Query Database Software Option for Platinum Elite 1 Multiuser, Multiuser Software Option for Platinum Elite 1 - Isothermal Lung, Isothermal Lung Model 1 - Gas Tank, E/D Size Calibration Air Gas Tank Yoke (5% Co2, 12% O2, Balance N2) 1 BreezeConnect HL7 Interface Description: BreezeConnect HL7 Interface Software for Orders and Results (Test and Production Software) Includes: 147751-001 Interface Base Software 147750-001 Connection License (Orders) 147750-001 Connection License (Results 147750-001 Connection License (Breeze) 147751-901 Interface Base Software (Test) 147750-901 Connection License (Test Orders) 147750-901 Connection License (Test Results) 147750-901 Connection License (Test Breeze) 950011-001 32 Hours Remote Installation Service 920017-003 One-Year Support, Maintenance & Licensing Agreement. Agreement Term will start the earlier of (1) 60 days after receipt of software or (2) upon go-live. Agreement must be renewed to retain support & software license. Server hardware is not provided by vendor. 1 - Operator Training, Two Day Onsite Operator Training (up to 4 People) 1 - Onsite Training, One Day Onsite Operator Training and Go-Live Support for BreezeConnect Interface and BreezeReview 1 UltraCare, Five-Year UltraCare Preferred Support Agreement for Elite 1 Vendor Credentialing Vendor access to the VA is by appointment only and requires credentialing through our vendor credentialing partner, Symplr at https://vcsdatabase.com/login Symplr registration is at cost to the vendor only and VA is not responsible for this. All vendors are required to check-in at the Symplr kiosk using their smart phone or desktop check-in with Symplr login and obtain a day badge, which will include date, time, and location of approved appointment. Company badge with photo ID is also required to be worn while onsite at any of the VA sites. Vendors are only permitted to visit the location identified on their Symplr generated badge and must exit the facility promptly, checking out via their smart phone once the scheduled appointment has ended. End Statement of Work Instructions to Vendors: The information identified above is intended to be descriptive, of a BRAND NAME OR EQUAL TO - MGC Diagnostics Platinum Elite DX Plethysmograph to indicate the quality of the supplies/services that will be satisfactory. It is the responsibility of the interested source to demonstrate to the government that the interested parties can provide the supplies/services that fulfill the required specifications mentioned above. Responses to this RFI should include company name, address, point of contact, phone number, and point of contact e-mail, DUNS Number, Cage Code, size of business pursuant to North American Industrial Classification System (NAICS) 334510 and /or 339112. Please answer the following questions: Please indicate the size status and representations of your business, such as but not limited to: Service-Disabled Veteran Owned Small Business (SDVOSB), Veteran Owned Small Business (VOSB), HUBZone, Woman Owned Small Business (WOSB), Large Business, etc.)? Is your company considered small under the NAICS code identified under this RFI? Are you the manufacturer, distributor, or an equivalent solution to the items being referenced above? If you are a large business, do you have any designated authorized distributors? If so, please provide their company name, telephone, point of Contact and size status (if available). (5) Describe how your small business takes ownership of the equipment in the manufacturing, assembly, or delivery process. (6) If you re a small business and you are an authorized distributor/reseller for the items identified above or an equivalent solution, do you alter; assemble; modify; the items requested in any way? If you do, state how and what is altered; assembled; modified? (7) If you intend to subcontract any work on this contract, what portion of the total cost will be self-performed/will be performed by your organization? Please provide estimated detailed percentage breakdowns related to subcontracted work and completion of job. (8) Does your company have an FSS contract with GSA or the NAC or are you a contract holder with any other federal contract? If so, please provide the contract number. (9) If you are an FSS GSA/NAC contract holder or other federal contract holder, are the items/solution you are providing information for available on your schedule/contract? General pricing of your products/solution is encouraged. Pricing will be used for the purpose of market research only. It will not be used to evaluate for any type of award. (10) Please submit your capabilities regarding the brand name equipment. (11) Please review salient characteristics/statement of work (if applicable) and provide feedback or suggestions. If none, please reply as N/A. This RFI will be conducted in accordance with Federal Acquisition Regulation (FAR) Part 13. Responses must be received via email to david.santiago2@va.gov no later than, 4 PM Eastern Standard Time (EST) on Friday June 20, 2025. This notice will help the VA in determining available potential sources only. Reference 36C24425Q0771 in the subject of the email response. Do not contact VA Medical Center staff regarding this requirement, as they are not authorized to discuss this matter related to this procurement action. All questions will be addressed by the Contracting Specialist, David Santiago. All firms responding to this Request for Information are advised that their response is not a request for proposal, therefore will not be considered for a contract award. If a solicitation is issued, information will be posted on the beta.Sam web site for all qualified interested parties at a later date and interested parties must respond to this notification to be considered for a set-aside. This notice does not commit the government to contract for any supplies or services. The government will not pay for any information or administrative cost incurred in response to this Request for Information. Information will only be accepted in writing by email to Contracting Specialist at david.santiago2@va.gov DISCLAIMER This RFI is issued solely for information and planning purposes only and does not constitute a solicitation. All information received in response to this RFI that is marked as proprietary will be handled accordingly. Responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this RFI. End Sources Sought Notice
