6505--INO Nitric Oxide

Published Date
October 5th, 2023
Response Deadline
October 13th, 2023
Department of Veterans Affairs VA Pittsburgh Healthcare System University Drive Campus University Drive
Pittsburgh, 15240-2400, USA
Notice Type
Sources Sought
Solicitation No.






Sources Sought VETERANS AFFAIRS, DEPARTMENT OF is seeking information and potential qualified sources capable of meeting the minimum requirements and salient characteristics for INOmax®. INOmax is a pharmaceutical drug used for inhalation therapy treatments at the VA Pittsburgh Healthcare System. The contract includes the provision of INOmax, delivery devices, maintenance and calibration items, training, support, and other services. The contract will be for a period of five years. Interested parties should provide company information, size status, and representations, as well as their capabilities and feedback on the salient characteristics. Responses must be submitted by October 13, 2023, via email to sherrie.thompson2@va.gov. This is a request for information only and does not constitute a solicitation.


THIS IS NOT A SOLICITATION ANNOUNCEMENT. THIS IS A REQUEST FOR INFORMATION ONLY. This Request for Information (RFI) is intended for information and planning purposes only at this time; and shall not be construed as a solicitation or as an obligation on the part of the Department of Veterans Affairs. Because this is a Request for Information announcement, no evaluation letters and/or results will be issued to the respondents. No solicitation exists. Therefore, do not request a copy of a solicitation. The Department of Veterans Affairs (VA), VISN 4, Network Contracting Office 4 (NCO 4), Philadelphia is seeking information and potential qualified sources capable of meeting the following minimum requirements and salient characteristics below for INOmax®. DESCRIPTION/SPECIFICATIONS/WORK STATEMENT (SOW) Statement Of Work: General Scope: The contractor shall provide the pharmaceutical drug INOmax (nitric oxide) Brand Name Only for inhalation therapy treatments at the VA Pittsburgh Healthcare when required. Listed below are the items included in this contract. INOtherapy Services - consists of (a) the pharmaceutical drug INOmax® (nitric oxide) for inhalation ( INOmax ), (b) a delivery device meeting the criteria for the administration of INOmax set forth in the product label for INOmax (the Delivery Device ) ventilator , (c) various maintenance and calibration items, accessories, and disposables, and (d) training, support, maintenance, pick-up and delivery, and other services. INOmax (nitric oxide) for inhalation portable aluminum cylinders: 64693-002-02 Size 88, 1963 liters @ STP of nitric oxide gas, 800ppm concentration 64693-001-02 Size 88, 1963 liters @ STP of nitric oxide gas, 100ppm concentration 64693-002-01 Size D, 353 liters @ STP of nitric oxide gas, 800ppm concentration 64693-001-01 Size D, 353 liters @ STP of nitric oxide gas, 100ppm concentration Use of Delivery Device meeting the criteria for the administration of INOmax set forth in the product label for INOmax INOcal purified calibration gases for calibrating the Delivery Device(s) Disposables, Adaptors, Parts, and Accessories Training & In Service 24/7 Technical & Customer Support Test Gas Program & Monthly System Check-Out Kits Routine Preventive Maintenance and Updates for Delivery Devices Replacement/Repair of Delivery Devices on an as needed basis Routine scheduled pick-ups and deliveries to provide Customer with appropriate levels of cylinders of INOmax and related supplies and disposable items Emergency Deliveries INOtherapy Systems (including Delivery Device(s), cylinders, calibration gas, disposables, etc.) on an as needed basis Reimbursement Support Services Vendor Information Requirements: Patient information (pursuant to all regulations dealing with patient privacy) will be provided at the time of the order. This information will be used to calculate usage for billing. Vendor agrees to notify the COR of any updates or improvements to the ventilator equipment are necessary. Vendor will work with COR to schedule any required training or education. Government Furnished Property: The government will furnish no property to the vendor. The government will furnish electrical power and other utilities for the operation of the ventilator and related equipment for both uses of the product as well as for training purposes. The government will furnish space for education, including access to standard classroom facilities for the purpose of educating staff if needed. Term Of Contract: This will be a BPA for five years. The BPA is subject to the availability of VA funds. No service shall be performed by the contractor after the end date until the Contracting Officer authorizes such services in writing. Legal Requirements Related To Medical Records/Privacy And Confidentiality: Contractor must adhere to the provisions of Public Law 104-191, Health Insurance Portability and Accountability Act (HIPAA) of 1996 and the National Standards to Protect the Privacy and Security of Protected Health Information (PHI).  As required by HIPAA, the Department of Health and Human Services (HHS) has promulgated rules governing the security, use, and disclosure of protected health information by covered entities, including the Department of Veterans Affairs (VA).  Records created by the Contractor in the course of treating patients under this contract are the property of VA and shall not be accessed, released, transferred or destroyed except in accordance with applicable federal law and regulations. The treatment and administrative patient records created by, or provided to, the Contractor under this contract are covered by the VA system of records entitled Patient Medical Records VA (24VA19), which is available at http://www.rms.oit.va.gov/SOR_Records/24VA19.asp The Contractor is required to comply with Title 48 of the Code of Federal Regulations, Part 24.101-24.104 Protection of Privacy and Freedom of Information . When responding to a veteran s request that copies of records is released to a third party, the Contractor shall refer the veteran to VA for release of records. The Contractor is responsible for complying with VHA, Joint Commission, HIPAA, and other applicable external regulatory agency regulations. Neither the VA nor the Contractor has the legal authority to require that a patient provide his/her Social Security Number to the VA as a condition for receiving medical care under Title 38, United States Code. If the patient does not provide a Social Security Number, the VA will assign a unique identification number to the patient. Delivery Location VA Pittsburgh Healthcare System University Drive C Pittsburgh, PA 15240 B. iNOtherapy Services is comprised of a drug, device and service. The pharmaceutical drug INOmax® (nitric oxide) for inhalation ( INOmax ) is a potent vasodilator primarily used for treatment of Pulmonary Hypertension. INOtherapy Services has shown to improve cardiac perfusion and improve outcomes when administered through a ventilator to patients undergoing high risk coronary artery bypass grafting (CABG) and liver transplants. Use of INOtherapy Services is initiated on the patient during surgery and is continued in the Intensive Care Unit. Request for Information Instructions The information identified above is intended to be descriptive, not restrictive and 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) 339113 (size standard of 1000 employees). Please answer the following questions: 1) 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.)? 2) Is your company considered small under the NAICS code identified under this RFI? 3) Are you the manufacturer, distributor, or an equivalent solution to the items being referenced above? If not, Can you provide additional information shown below. This is to confirm compliance with the non-manufacturer rule IAW 13 CFR 121.406(b) Nonmanufacturers. Does your company exceed 500 employees. Primarily engaged in the retail or wholesale trade and normally sells the type of item being supplied. Take ownership or possession of the item(s) with its personnel, equipment, or facilities in a manner consistent with industry practice. Obtained an individual or class waiver? 1) If you are a large business, do you have any designated distributors? If so, please provide their company name, telephone, point of Contact and size status (if available). 2) 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? 3) 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. 4) 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. 5) 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? 6) 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. 7) Please submit your capabilities in regard to the salient characteristics detailed above and any information pertaining to equal to items to establish capabilities for planning purposes? 8) Please review salient characteristics/statement of work (if applicable) and provide feedback or suggestions. If none, please reply as N/A. 9) Please provide your DUNS number. This RFI will be conducted in accordance with Federal Acquisition Regulation (FAR) Part 13. Telephone responses will not be accepted. Responses must be received via e-mail to no later sherrie.thompson2@va.gov than, 5 PM Eastern Standard Time (EST) on October 13, 2023, with 36C24424Q0007 in the subject line. This notice will help the VA in determining available potential sources only. 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, Sherrie Thompson. 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 the solicitation to be considered for award. 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 or Questions will only be accepted in writing by e-mail to Contracting Specialist at sherrie.thompson2@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.

Contact Information

PrimarySherrie ThompsonContract Specialist
(215) 823-5800
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